Systems and methods for positioning an elongate member inside a body

ABSTRACT

Systems and methods for introducing and driving flexible members in a patient&#39;s body are described herein. In one embodiment, a robotic method includes positioning a flexible elongated member that has a preformed configuration, wherein at least a part of the flexible elongated member has a first member disposed around it, and wherein the first member includes a first wire for bending the first member or for maintaining the first member in a bent configuration, releasing at least some tension in the first wire to relax the first member, and advancing the first member distally relative to the flexible elongated member while the first member is in a relaxed configuration.

RELATED APPLICATION DATA

This application is a divisional of U.S. patent application Ser. No.16/746,728, filed on Jan. 17, 2020, which is a continuation of U.S.patent application Ser. No. 16/165,375, filed Oct. 19, 2018, issued asU.S. Pat. No. 10,555,780 on Feb. 11, 2020, which is a continuation ofSer. No. 14/603,836, filed Jan. 23, 2015, issued as U.S. Pat. No.10,130,427 on Nov. 20, 2018, which is a continuation of U.S. patentapplication Ser. No. 13/174,536, filed Jun. 30, 2011, now abandoned,entitled “SYSTEMS AND METHODS FOR POSITIONING AN ELONGATE MEMBER INSIDEA BODY,” which claims priority to and the benefit of U.S. ProvisionalPatent Application No. 61/384,220, filed Sep. 17, 2010, and U.S.Provisional Application No. 61/482,598, filed May 4, 2011, the entiredisclosures of all of which are expressly incorporated by referenceherein for all purposes.

This application is related to U.S. patent applications entitled“Steerable catheters” having Ser. No. 13/173,994, issued as U.S. Pat.No. 8,827,948 on Sep. 9, 2014, “Robotic medical systems and methods”having Ser. No. 13/174,455, now abandoned, “Anti-buckling mechanisms andmethods” having Ser. No. 13/174,563, issued as U.S. Pat. No. 8,961,533on Feb. 24, 2015, “Systems and methods for manipulating an elongatemember” having Ser. No. 13/174,563, issued as U.S. Pat. No. 9,314,306 onApr. 19, 2016, and “User interface and method for operating a roboticmedical system” having Ser. No. 13/174,638, now abandoned, all filed onJun. 30, 2011, the entire disclosures of all of which are expresslyincorporated by reference herein for all purposes.

INCORPORATION BY REFERENCE

All of the following U.S. patent applications are expressly incorporatedby reference herein for all purposes:

U.S. patent application Ser. No. 11/179,007, filed on Jul. 6, 2005,issued as U.S. Pat. No. 7,850,642 on Dec. 14, 2010,

U.S. patent application Ser. No. 12/079,500, filed on Mar. 26, 2008,issued as U.S. Pat. No. 8,391,957 on Mar. 5, 2013,

U.S. patent application Ser. No. 11/678,001, filed on Feb. 22, 2007,issued as U.S. Pat. No. 8,092,397 on Jan. 10, 2012,

U.S. Patent Application No. 60/801,355, filed on May 17, 2006,

U.S. patent application Ser. No. 11/804,585, filed on May 17, 2007, nowabandoned,

U.S. patent application Ser. No. 11/640,099, filed on Dec. 14, 2006,issued as U.S. Pat. No. 8,498,691 on Jul. 30, 2013,

U.S. patent application Ser. No. 12/507,727, filed on Jul. 22, 2009, nowabandoned,

U.S. patent application Ser. No. 12/106,254, filed on Apr. 18, 2008,issued as U.S. Pat. No. 8,050,523 on Nov. 1, 2011,

U.S. patent application Ser. No. 12/192,033, filed on Aug. 14, 2008,issued as U.S. Pat. No. 9,186,046 on Nov. 17, 2015,

U.S. patent application Ser. No. 12/236,478, filed on Sep. 23, 2008,issued as U.S. Pat. No. 8,989,528 on Mar. 24, 2015,

U.S. patent application Ser. No. 12/833,935, filed on Jul. 9, 2010, nowabandoned,

U.S. patent application Ser. No. 12/822,876, filed on Jun. 24, 2010,issued as U.S. Pat. No. 8,460,236 on Jun. 11, 2013, and

U.S. patent application Ser. No. 12/614,349, filed on Nov. 6, 2009,issued as U.S. Pat. No. 8,720,448 on May 13, 2014.

FIELD

The application relates generally to robotically controlled surgicalsystems, and more particularly to flexible instruments and instrumentdrivers that are responsive to a master controller for performingsurgical procedures.

BACKGROUND

Robotic surgical systems and devices are well suited for use inperforming minimally invasive medical procedures, as opposed toconventional techniques wherein the patient's body cavity is open topermit the surgeon's hands access to internal organs. For example, thereis a need for a highly controllable yet minimally sized system tofacilitate imaging, diagnosis, and treatment of tissues which may liedeep within a patient, and which may be preferably accessed only vianaturally-occurring pathways such as blood vessels or thegastrointestinal tract.

SUMMARY

The subject application describes, among other things, a robotic systemfor controlling an elongate instrument. By means of non-limitingexamples, the elongate instrument may include a catheter and a sheathsurrounding at least a part of the catheter or other flexible andelongated medical instruments. In some embodiments, the sheath may beconsider a catheter itself. Also, in other embodiments, the elongateinstrument may optionally further include a guidewire that is at leastpartially surrounded by the catheter.

The elongate instrument may have different configurations in differentembodiments. In accordance with some embodiments, an elongated medicaldevice includes an elongated body having a proximal section, a distalsection, and a working lumen extending through the proximal and distalsections, a first coil having a distal portion, and a proximal portion,the proximal portion of the first coil being slidable relative to theproximal section of the elongated body, and being closer to a wall ofthe elongated body than to an axis of the elongated body, wherein alengthwise portion of the distal portion of the first coil is anchoredto the distal section of the elongated body, and a first steering wirelocated within a lumen of the first coil. By means of non-limitingexamples, the elongated medical device may be a catheter, a sheath, orany medical instrument having a working lumen. In one or more of theembodiments described herein, the working lumen may have a crosssectional area that is at least 30% of a cross sectional area of theelongated body. In one or more of the embodiments described herein, thelengthwise portion may be at least 10 mm. Also, in one or more of theembodiments described herein, the lengthwise portion may be at least 5%of an entire length of the first coil. In one or more of the embodimentsdescribed herein, the elongated body may have a proximal tip, and theproximal portion of the first coil may have a proximal tip that isproximal to the proximal tip of the elongated body.

The elongated medical device may have a variety of differentconfigurations in different embodiments. In one or more of theembodiments described herein, the first coil may be anchored to theelongated body at a transition location between the proximal and distalsections of the elongated body. In one or more of the embodimentsdescribed herein, a loop at the distal portion of the first coil may beembedded into a wall of the distal section of the elongated body.

Also, in some embodiments described herein, the device may include asecond coil having a distal portion anchored to the distal section ofthe elongated body, and a proximal portion slidable relative to theproximal section of the elongated body, and a second steering wirelocated within a lumen of the second coil. The steering wires allow thedevice to be steered in different directions during use.

The device may be mechanically driven in some embodiments. For example,in one or more of the embodiments described herein, the device mayinclude a drivable instrument coupled to a proximal end of the elongatedbody and to the first and second steering wires, wherein the drivableinstrument is configured to apply tension to the first and secondsteering wires. Also, in one or more of the embodiments describedherein, the device may include a processor coupled to the drivableinstrument, the processor configured to receive a user command andgenerate a control signal based on the user command to control thedrivable instrument.

The device may also optionally include other features in differentembodiments. For example, in one or more of the embodiments describedherein, the device may include first and second hypotubes fixedlysecured to the drivable instrument, wherein the proximal portion of thefirst coil is secured to the first hypotube, and the proximal portion ofthe second coil is secured to the second hypotube. Also, in one or moreof the embodiments described herein, the device may include a linersurrounding the proximal portion of the first coil, wherein the firstcoil is slidable relative to the liner.

In some embodiments, the elongated body may be a body of a catheter, aguidewire, or another elongated device. In such cases, the device mayinclude an additional elongated body that is movably disposed around atleast a part of the elongated body. The additional elongated body may beanother catheter, a sheath, or another elongated device.

In some embodiments, the elongated medical device may have a steerabledistal section and a proximal section that remains very flexible evenwhile the distal section is being steered. Also, one or more of theembodiments described herein, the first coil and the first steering wiremay be configured to maintain a bent configuration for the distalsection of the elongated body, while allowing the proximal section ofthe elongated body to remain flexible.

The elongate instrument may have other configurations in otherembodiments. For example, in accordance with other embodiments, anelongated medical device includes an elongated body having a proximalsection, a distal section, and a working lumen extending through theproximal and distal sections, a first coil, wherein at least alengthwise portion of the first coil is anchored to the distal sectionof the elongated body, a second coil in the proximal section of theelongated body that is slidable relative to the proximal section of theelongated body, wherein the second coil is axially aligned with thefirst coil along a length of the elongated body, and a steering wirelocated within a lumen of the first coil and within a lumen of thesecond coil. In one or more of the embodiments described herein, thelengthwise portion may be at least 10 mm. Also, in one or more of theembodiments described herein, the lengthwise portion may be at least 5%of a combined length of the first coil and the second coil. In one ormore of the embodiments described herein, the first coil may be embeddedwithin a wall of the elongated body. Also, in one or more of theembodiments described herein, a distal end of the second coil may beanchored to the elongate body at a location in which there is atransition between the first and second coils. In some embodiments, eachof the first coil and the second coil may have an open pitch. In otherembodiments, each of the first coil and the second coil may have aclosed pitch. In further embodiments, the first coil may have an openpitch, and the second coil may have a closed pitch. In some embodiments,the first coil, the second coil, and the steering wire may be configuredto maintain a bent configuration for the distal section of the elongatedbody, while allowing the proximal section of the elongated body toremain flexible. Also, in one or more of the embodiments describedherein, the elongated body may have a proximal tip, and the second coilmay have a proximal tip that is proximal to the proximal tip of theelongated body.

The device may be mechanically driven in some embodiments. For example,in some embodiments, the device may include a drivable instrumentcoupled to a proximal end of the elongated body and to the steeringwire, wherein the drivable instrument is configured to apply tension tothe steering wire. Also, in some embodiments, the device may include aprocessor coupled to the drivable instrument, the processor configuredto receive a user command and generate a control signal based on theuser command to control the drivable instrument.

The device may optionally include other features in other embodiments.For example, in one or more of the embodiments described herein, thedevice may include a hypotube fixedly secured to the drivableinstrument, wherein a proximal portion of the second coil is secured tothe hypotube. Also, in one or more of the embodiments described herein,the device may include a liner surrounding the second coil, wherein thesecond coil is slidable relative to the liner.

In some embodiments, the elongated body may be a body of a catheter, aguidewire, or another elongated device. In such cases, the device mayinclude an additional elongated body that is movably disposed around atleast a part of the elongated body.

Embodiments of the elongated medical device described herein may be usedto perform different procedures in different embodiments. In accordancewith some embodiments, a method performed using an elongated medicaldevice includes providing the elongated medical device having anelongated body having a proximal section, a distal section, and aworking lumen extending through the proximal and distal sections, afirst coil having a distal portion and a proximal portion, and a firststeering wire located within a lumen of the first coil, and applyingtension to the first steering wire, while allowing the proximal portionof the first coil to slide relative to the proximal section of theelongated body, wherein while the tension is being applied to the firststeering wire, a lengthwise portion of the distal portion of the firstcoil is prevented from being moved relative to the distal section of theelongated body. In one or more of the embodiments described herein, thelengthwise portion may be at least 10 mm. Also, in one or more of theembodiments described herein, the lengthwise portion may be at least 5%of an entire length of the first coil. In one or more of the embodimentsdescribed herein, the elongated medical device may further include asecond coil having a distal portion anchored to the distal section ofthe elongated body, and a proximal portion slidable relative to theproximal section of the elongated body, and a second steering wirelocated within a lumen of the second coil.

During the method, in some embodiments, the first coil may be preventedfrom being moved relative to the elongated body at a first region thatis distal to a transition location between the proximal and distalsections of the elongated body, and may be allowed to slide relative tothe elongated body at a second region that is proximal to the transitionlocation. Also, in other embodiments, the lengthwise portion of thedistal portion of the first coil may be prevented from being moved byembedding a loop at the distal portion of the first coil into a wall ofthe distal section of the elongated body.

The method may be performed using a robotic system in some embodiments.For example, in some embodiments, the tension may be applied using adrivable instrument. Also, in one or more of the embodiments describedherein, the method may include generating a control signal by aprocessor based on a user command received by the processor, wherein thedrivable instrument applies the tension to the first steering wire inresponse to the control signal.

In one or more of the embodiments described herein, the tension may beapplied to steer the distal section of the elongated body while steeringforce may be isolated from the proximal section of the elongated body.Also, in some embodiments described herein, the tension may be appliedto steer the distal section while a bending stiffness of the proximalsection of the elongated body is not significantly affected. In stillfurther embodiments, the tension may be applied to steer the distalsection of the elongated body without creating unwanted curvature at theproximal section of the elongated body. In other embodiments describedherein, the tension may be applied to steer the distal section of theelongated body while a shape of the proximal section of the elongatedbody is unaffected by the steering of the distal section.

The elongate instrument that may be used with the robotic system mayhave other configurations in other embodiments. For example, inaccordance with other embodiments, an elongated medical device includesan elongated body having a proximal section, a distal section, and aworking lumen extending through the proximal and distal sections,wherein the distal section has a tapered profile, a first coil having adistal portion anchored to the distal section of the elongated body, anda proximal portion slidable relative to the proximal section of theelongated body, a first steering wire located within a lumen of thefirst coil, a second coil having a distal portion anchored to the distalsection of the elongated body, a second steering wire located within alumen of the second coil, a control ring located at the distal sectionof the elongated body, and a spine located in the elongated body,wherein the first coil and the second coil are located radially awayfrom an axis of the spine. In one or more of the embodiments describedherein, the working lumen may have a tapered configuration. Also, in oneor more of the embodiments described herein, the device may include adrivable instrument coupled to a proximal end of the elongated body andto the first and second steering wires, wherein the drivable instrumentis configured to apply tension to the first and second steering wires.In one or more of the embodiments described herein, the device mayinclude a processor coupled to the drivable instrument, the processorconfigured to receive a user command and generate a control signal basedon the user command to control the drivable instrument.

The robotic system may control the elongate instrument in differentconfigurations. In accordance with some embodiments, a robotic surgicalsystem includes a flexible elongated member, a first member movablydisposed around at least a portion of the flexible elongated member, asecond member movably disposed around at least a portion of the firstmember, a drive assembly coupled to each of the flexible elongatedmember, the first member, and the second member, and a control interfacefor receiving an input command from a user, wherein the drive assemblyis configured to automatically move one or both of the first member andthe second member while maintaining the flexible elongated member at afixed axial position in response to the received input command.

In some embodiments, the drive assembly may be configured to move thefirst member distally, without moving the second member, whilemaintaining the flexible elongated member at the fixed position, inresponse to the received input command. Also, in some embodiments, thedrive assembly may be configured to move the first member proximally,without moving the second member, while maintaining the flexibleelongated member at the fixed position, in response to the receivedinput command. In other embodiments, the drive assembly may beconfigured to move the second member distally, without moving the firstmember, while maintaining the flexible elongated member at the fixedposition, in response to the received input command. In furtherembodiments, the drive assembly may be configured to move the secondmember proximally, without moving the first member, while maintainingthe flexible elongated member at the fixed position, in response to thereceived input command. In still further embodiments, the drive assemblymay be configured to move each of the first member and the second memberdistally, while maintaining the flexible elongated member at the fixedposition, in response to the received input command. In otherembodiments, the drive assembly may be configured to move each of thefirst member and the second member proximally, while maintaining theflexible elongated member at the fixed position, in response to thereceived input command.

In one or more of the embodiments described herein, the first member mayinclude a first pull wire, and wherein the drive assembly may be furtherconfigured to adjust a tension in the first pull wire. In someembodiments, the drive assembly may be configured to move the firstmember proximally relative to the second member after releasing at leastsome tension in the first pull wire, while maintaining the flexibleelongated member at the fixed position, in response to the receivedinput command. In other embodiments, the second member may include asecond pull wire, and wherein the drive assembly may be furtherconfigured to adjust a tension in the second pull wire. In furtherembodiments, the drive assembly may be configured to move each of thefirst member and the second member proximally relative to the flexibleelongated member after releasing at least some tension in the secondpull wire, while maintaining the flexible elongated member at the fixedposition, in response to the received input command. Also, in someembodiments, the drive assembly may be configured to translate and/orrotate the flexible elongated member.

In some embodiments, the flexible elongated member may include aguidewire. In one or more of the embodiments described herein, theguidewire may have a preformed configuration. Also, in one or more ofthe embodiments described herein, the system may include a mechanism forcontrolling and/or maintaining the preformed configuration.

In accordance with other embodiments, a robotic surgical system includesa member having a first controllable section and a second controllablesection distal of the second controllable section, a drive assemblycoupled to the tubular member, and a control interface for allowing auser to select one of the first and second controllable sections of thetubular member to move, wherein the drive assembly is configured toindependently move the first controllable section or the secondcontrollable section in response to an input command from the userreceived at the control interface. In one or more of the embodimentsdescribed herein, the first controllable section and the secondcontrollable section may be in a telescopic configuration. In someembodiments, the drive assembly may be configured to move the firstcontrollable section while maintaining the second controllable sectionin a fixed position. Also, in some embodiments, the first controllablesection may have a bent configuration, and the drive assembly may beconfigured to move the second controllable section while maintaining thebent configuration for the first controllable section. In someembodiments, the system may include a flexible elongated member disposedinside the tubular member, wherein the drive assembly is configured tomove the member while maintaining the flexible elongated member at afixed position. Also, in other embodiments, the drive assembly may beconfigured to translate and/or rotate the flexible elongated member.

In some embodiments, the flexible elongated member may include aguidewire. In one or more of the embodiments described herein, theguidewire may have a preformed configuration. Also, in one or more ofthe embodiments described herein, the system may include a mechanism forcontrolling and/or maintaining the preformed configuration.

The robotic surgical system may have other configurations in otherembodiments. For example, in accordance with other embodiments, arobotic surgical system includes an elongate member having a pre-shapedconfiguration, a member disposed over the elongate member, a driveassembly coupled to the elongate member and the member, and a controlinterface for receiving an input command from a user, wherein the driveassembly is configured to move the member distally relative to theelongate member along the pre-shaped configuration of the elongatemember in response to the input command received at the controlinterface.

In some embodiments, the elongate member may include a flexibleelongated member. In one or more of the embodiments described herein,the flexible elongated member may include a guidewire. Also, in someembodiments, the drive assembly may be configured to translate and/orrotate the guidewire. In other embodiments, the elongate member may havea tubular configuration. In one or more of the embodiments describedherein, the tubular member may include a pull wire located in a wallthereof, and wherein the drive assembly may be configured to adjust atension in the pull wire before moving the tubular member distallyrelative to the elongate member.

Also, in other embodiments, the robotic system may control two elongatemembers of an elongate instrument in a telescopic fashion to therebyadvance the elongate instrument inside a body. For example, inaccordance with some embodiments, a robotic method includes positioninga flexible elongated member that has a preformed configuration, whereinat least a part of the flexible elongated member has a first memberdisposed around it, and wherein the first member includes a first wirefor bending the first member or for maintaining the first member in abent configuration, releasing at least some tension in the first wire torelax the first member, and advancing the first member distally relativeto the flexible elongated member while the first member is in a relaxedconfiguration. In some embodiments, the act of positioning the flexibleelongated member may include advancing the flexible elongated member.Also, in some embodiments, the act of positioning the flexible elongatedmember may include using a drive mechanism. In some embodiments, thefirst member may include a tubular member. Also, in some embodiments,the flexible elongated member may include a guidewire. In one or more ofthe embodiments described herein, the guidewire may have a preformedconfiguration. In other embodiments, the act of positioning may includeadvancing and/or rotating the flexible elongated member.

In other embodiments, the method may include re-tensioning the firstwire to stiffen the first member. Also, in other embodiments, the methodmay include repeating the acts of releasing at least some tension andadvancing the first member. In still further embodiments, at least apart of the first member may have a second member disposed around it,and wherein the second member may include a second wire for bending thesecond member or for maintaining the second member in a bentconfiguration, and the method may include releasing at least sometension in the second wire to relax the second member, and advancing thesecond member distally relative to the flexible elongated member whilethe second member is in a relaxed configuration.

In some embodiments, the acts of advancing the first member and thesecond member may be performed simultaneously so that both the firstmember and the second member are advanced together. In otherembodiments, the first member may be advanced before the second member.In further embodiments, the method may include re-tensioning the firstwire to stiffen the first member, and re-tensioning the second wire tostiffen the second member. In still further embodiments, the firstmember may be advanced until a distal end of the first member has passedthrough an opening in a body.

The method may be performed using a drivable instrument in accordancewith some embodiments. For example, in some embodiments, the first wiremay be coupled to a drivable instrument, and wherein the at least sometension in the first wire may be released by the drivable instrument inresponse to a control signal received from a processor. Also, in someembodiments, the first member may be coupled to a drivable instrument,and wherein the first member may be advanced by the drivable instrumentin response to a control signal received from a processor.

In accordance with other embodiments, a robotic method includes rollinga first member, wherein the first member is disposed around a flexibleelongated member, positioning the flexible elongated member tocompensate for the rolling of the first member. In one or more of theembodiments described herein, the act of rolling the first member mayinclude rotating the first member about its longitudinal axis. In one ormore of the embodiments described herein, the act of rolling the firstmember may include bending the first member in different radialdirections to create an artificial rolling.

In accordance with other embodiments, a robotic system includes aflexible elongated member that has a preformed configuration, a firstmember disposed around at least a part of the flexible elongated member,wherein the first member includes a first wire, a drive assemblyconfigured to position the flexible elongated member, a first drivemechanism configured to manipulate the first wire to bend the firstmember or to maintain the first member in a bent configuration, a seconddrive mechanism configured to move the first member relative to theflexible elongated member, and a controller coupled to the first drivemechanism and the second drive mechanism, wherein the controller isconfigured to transmit first control signals to operate the first drivemechanism so that the first drive mechanism releases at least sometension in the first wire to relax the first member, and to operate thesecond drive mechanism to advance the first member distally relative tothe flexible elongated member while the first member is in a relaxedconfiguration. In some embodiments, the drive assembly may be configuredto advance the flexible elongated member distally relative to the firstmember. In other embodiments, the controller may be configured tooperate the first drive mechanism to re-tension the first wire tostiffen the first member after the first member is relaxed. Also, inother embodiments, the controller may be configured to operate the firstand second drive mechanisms to repeat the acts of releasing at leastsome tension and advancing the first member.

In one or more of the embodiments described herein, the system mayinclude a second member disposed around at least a part of the firstmember, wherein the second member includes a second wire, a third drivemechanism configured to manipulate the second wire to bend the secondmember or to maintain the second member in a bent configuration, and afourth drive mechanism configured to move the second member, wherein thecontroller may be further configured to transmit second control signalsto operate the third drive mechanism to release at least some tension inthe second wire to relax the second member, and to operate the fourthdrive mechanism to advance the second member distally relative to theflexible elongated member while the second member is in a relaxedconfiguration. In some embodiments, the controller may be configured tocontrol the second drive mechanism and the fourth drive mechanism toadvance the first member and the second member together andsimultaneously. In other embodiments, the controller may be configuredto cause the first member to be advanced before the second member. Infurther embodiments, the controller may be configured to operate thefirst drive mechanism to re-tension the first wire to stiffen the firstmember, and to operate the third drive mechanism to re-tension thesecond wire to stiffen the second member.

Embodiments of the system described herein may be used to performvarious methods in different embodiments. In accordance with someembodiments, a robotic method includes inserting a first elongate memberand a second elongate member into a body, wherein the second elongatemember is slidably disposed around at least a portion of the firstelongate member, applying tension to one or more steering wires in thefirst elongate member to bend a distal portion of the first elongatemember, maintaining the applied tension so that the bent distal portionof the first elongate member stays stiffened, and advancing the secondelongate member distally relative to the first elongate member whileusing the stiffened distal portion of the first elongate member as afirst guide to direct the second elongate member. In some embodiments,the method may also include releasing at least some tension in one ormore steering wires in the second elongate member to un-stiffen thesecond elongate member before the act of advancing. In some embodiments,the first elongate member may include a catheter, and the secondelongate member may include a sheath. Also, in some embodiments, thesecond elongate member may not include any steering wire.

In one or more of the embodiments described herein, after the act ofadvancing, the method may include releasing at least some tension in theone or more steering wires in the first elongate member to un-stiffenthe first elongate member, applying tension to one or more steeringwires in the second elongate member to bend a distal portion of thesecond elongate member, maintaining the applied tension in the one ormore steering wires in the second elongate member so that the bentdistal portion of the second elongate member stays stiffened, andadvancing the first elongate member distally relative to the secondelongate member while using the stiffened distal portion of the secondelongate member as a second guide to direct the first elongate member

In some embodiments, the method may include adjusting the appliedtension. In one or more of the embodiments described herein, the appliedtension may be adjusted automatically. Also, in one or more of theembodiments described herein, the tension may be adjusted to maintainthe distal portion of the first elongate member in a desired bentconfiguration.

The robotic system may also optionally include an anti-buckling devicefor supporting the elongate instrument as the elongate instrument isbeing advanced into the body in accordance with some embodiments. Suchfeature may prevent the elongate instrument from buckling.

One or more of the embodiments of the robotic system described hereinmay optionally further include a mechanism for preventing buckling ofthe elongate instrument. For example, in accordance with someembodiments, an anti-buckling device includes a first coupler forcoupling to a first device, a second coupler for coupling to a seconddevice that is configured to position a catheter member, a first set ofsupport members coupled between the first coupler and the secondcoupler, and a plurality of holders coupled to the support members, theholders configured for supporting the catheter member, wherein the firstset of support members form a support frame that can be extended bymoving the first and second couplers away from each other, and can becollapsed by moving the first and second couplers towards each other. Insome embodiments, the first set of support members may form a planarconfiguration. Also, in some embodiments, the device may further includea second set of support members that are disposed next to the first setof support members. In one or more of the embodiments described herein,the second set of support members may be configured to maintain theholders in a same orientation relative to each other, wherein theorientation may be perpendicular to a longitudinal axis of the cathetermember. In further embodiments, the device may include a third set ofsupport members that are disposed between the first and second sets ofsupport members. In one or more of the embodiments described herein, thethird set of support members may be configured to maintain the holdersin a same orientation relative to each other. Also, in some embodiments,the support members may be arranged in a scissor-like configuration. Inone or more of the embodiments described herein, the first set ofsupport members may be configured to provide a variable bucklingresistance for the catheter member supported by the support members inresponse to an advancement of the catheter member. In some embodiments,the first device may include a stabilizer that is configured to beattached to a patient. Also, in some embodiments, the first device mayinclude a first driver and the second device comprises a second driver.

The holders in the anti-buckling device may have different features indifferent embodiments. For example, in one or more of the embodimentsdescribed herein, each of the holders may have an opening foraccommodating a portion of the catheter member supported by the holders.Also, in one or more of the embodiments described herein, the holdersmay be moveable relative to a catheter member supported by the holdersin a manner such that the holders are maintained at a substantiallyequal distance from one another as they are moved.

Other devices for supporting an elongate member are also describedherein. For example, in accordance with other embodiments, a supportdevice includes a first set of support members arranged in ascissor-like configuration to form a support frame, wherein the supportframe has a first end and a second end, and can be extended by movingthe first and second ends away from each other, or collapsed by movingthe first and second ends towards each other, and a plurality of holderscoupled to the support members, the holders configured for supporting acatheter member, wherein the holders are moveable relative to thecatheter member supported by the holders, such that the holders aremaintained at a substantially same distance from one another regardlessof a distance between the first and second ends of the support frame. Insome embodiments, the device may include a first coupler disposed at thefirst end of the support frame for coupling to a driver that isconfigured to position a catheter member. Also, in some embodiments, thedevice may include a second coupler disposed at the second end of thesupport frame for coupling to a stabilizer that is configured to beattached to a patient. In one or more of the embodiments describedherein, the device may include a second coupler disposed at the secondend of the support frame for coupling to a driver. Also, in one or moreof the embodiments described herein, the support members may form ascissor-like configuration. In some embodiments, each of the holders mayhave an opening for accommodating a portion of the catheter membersupported by the holders. Also, in some embodiments, the support framemay be configured to provide a variable buckling resistance for thecatheter member supported by the holders in response to an advancementof the catheter member.

In some embodiments, the device may include a second set of supportmembers disposed next to the first set of support members. In one ormore of the embodiments described herein, the second set of supportmembers may be configured to maintain the holders in a same orientationrelative to each other. In further embodiments, the device may include athird set of support members disposed between the first and second setsof support members. In one or more of the embodiments described herein,the third set of support members may be configured to maintain theholders in a same orientation relative to each other.

The anti-buckling device may have different configurations in differentembodiments. For example, in accordance with other embodiments, ananti-buckling device includes a first coupler for coupling to a firstdevice, a second coupler for coupling to a second device, a first set ofsupport members disposed between the first and second couplers, whereinthe first set of support members are arranged in a scissor-likeconfiguration, and a plurality of holders coupled to the first set ofsupport members, the holders configured for supporting an elongatedmedical device. In some embodiments, the elongated medical device mayinclude a catheter member, an endoscope, or an ablation device. Also, insome embodiments, the first set of support members may be configured toprovide a variable buckling resistance for the elongated medical devicebeing supported by the holders in response to an advancement of theelongated medical device.

Devices having other configurations that are configured to support anelongate instrument are also described herein. For example, inaccordance with other embodiments, a support system includes a firstelongated member with a lumen, a second elongated member slidablydisposed within the lumen of the first elongated member, a firstanti-buckling device configured to support the first elongated member,and a second anti-buckling device configured to support the secondelongated member. In some embodiments, the first elongated member mayinclude a sheath, and the second elongated member comprises a catheter.Also, in some embodiments, the first anti-buckling device may includesupport members arranged in a scissor-like configuration. In one or moreof the embodiments described herein, the support members may includetelescoping tubes. Also, in one or more of the embodiments describedherein, the first anti-buckling device may have a first end configuredto detachably couple to a first drive assembly, and a second endconfigured to detachably couple to a patient. In one or more of theembodiments described herein, the second anti-buckling device may have afirst end configured to detachably couple to a second drive assembly,and a second end configured to detachably couple to the first driveassembly.

The support system may have different configurations in differentembodiments. For example, in accordance with other embodiments, asupport system includes a catheter having a first end for insertion intoa patient, and a second end for coupling to a first drive assembly, anda first anti-buckling device configured to laterally support thecatheter as the first end of the catheter is being advanced distally bythe first drive assembly. In some embodiments, the system may include asheath with a first end for insertion into the patient, a second end forcoupling to a second drive assembly, and a lumen in which the catheteris slidably disposed, and a second anti-buckling device configured tolaterally support the sheath as the sheath is being advanced by thesecond drive assembly. Also, in some embodiments described herein, thesystem may include the first drive assembly and the second driveassembly. In one or more of the embodiments described herein, the firstanti-buckling device may have a first end configured to detachablycouple to the first drive assembly, and a second end configured todetachably couple to the second drive assembly. Also, in one or more ofthe embodiments described herein, the second anti-buckling device mayhave a first end configured to detachably couple to the second driveassembly, and a second end configured to detachably couple to thepatient. In one or more of the embodiments described herein, the firstanti-buckling device may include support members arranged in ascissor-like configuration.

Embodiments of the anti-buckling/support device may be used to performdifferent methods in different embodiments. For example, in accordancewith some embodiments, a method includes advancing a first flexibleelongated member distally relative to a patient, and laterallysupporting at least a part of the first flexible elongated member usinga first anti-buckling device to prevent the first flexible elongatedmember from buckling during the act of advancing. In some embodiments,the act of laterally supporting at least a part of the first flexibleelongated member may include providing a plurality of lateral supportsalong a length of the first flexible elongated member, and wherein thelateral supports may be slidable relative to the first flexibleelongated member. Also, in some embodiments, the method may includechanging a spacing of the lateral supports in response to the act ofadvancing. In other embodiments, the method may include advancing asecond flexible elongated member distally relative to the patient, thesecond flexible elongated member disposed circumferentially around thefirst flexible elongated member, and laterally supporting at least apart of the second flexible elongated member using a secondanti-buckling device to prevent the second flexible elongated memberfrom buckling during the act of advancing the second flexible elongatedmember. In one or more of the embodiments described herein, the firstflexible elongated member may include a catheter.

The robotic system may also optionally include a manipulator formanipulating an elongate member, such as a guidewire, in accordance withsome embodiments. For example, in accordance with some embodiments, anelongate member manipulator includes an elongate member holder havingfirst and second rotary members configured to hold an elongate member,wherein the rotary members are actuated in opposite rotationaldirections to generate a corresponding linear motion of the elongatemember held by the rotary members along a longitudinal axis of theelongate member, and wherein the rotary members are actuated in oppositelinear directions to generate a corresponding rotational motion of theelongate member held by the rotary members about the longitudinal axisof the elongate member. In some embodiments, the manipulator may includea drive assembly for actuation of the first and second rotary members,wherein the elongate member holder is releasably coupled to the driveassembly. Also, in some embodiments, the manipulator may include asterile barrier positioned between the drive assembly and the elongatemember holder, wherein the drive assembly is configured to transferrotational motion across the sterile barrier to the rotary members togenerate the corresponding linear motion of the elongate member alongthe longitudinal axis of the elongate member. In other embodiments, themanipulator may include a sterile barrier positioned between the driveassembly and the elongate member holder, wherein the drive assembly isconfigured to transfer linear motion across the sterile barrier to therotary members to generate the corresponding rotational motion of theelongate member about the longitudinal axis of the elongate member.

In one or more of the embodiments described herein, the drive assemblymay be configured to actuate the rotary members in rotational and lineardirections simultaneously. Also, in one or more of the embodimentsdescribed herein, the rotary members may be actuated in the rotationaland linear directions at different respective rates. Also, in one ormore of the embodiments described herein, the drive assembly may beconfigured to provide rotational actuation and linear actuation for therotary members separately, and wherein the rotary members may beconfigured to maintain engagement with the elongate member between therotational actuation and linear actuation of the rotary members.

In some embodiments, the elongate member may include a guide wire. Also,in some embodiments, the first and second rotary members may includefirst and second feed rollers. In one or more of the embodimentsdescribed herein, the first feed roller may have a groove cut around anouter diameter of the first feed roller, wherein the groove may beconfigured for receiving an elongate member. Also, in one or more of theembodiments described herein, the first feed roller may be motor drivenand the second feed roller may be idle. In addition, in someembodiments, the first rotary member may include a first flexible memberwith a first engagement surface, and the second rotary member mayinclude a second flexible member with a second engagement surface. Also,in some embodiments, the first rotary member may be motor driven and thesecond rotary member may be idle. In further embodiments, themanipulator may include an elongate member support configured to holdthe elongate member and to prevent buckling of the elongate memberduring rotational or linear motion of the elongate member. Also, in someembodiments, the rotary members may include a first rotary member and asecond rotary member, and the first rotary member is a first feed beltassembly comprising two or more belts with spacing between the belts toaccommodate at least a portion of the elongate member support. Infurther embodiments, the second rotary member may include a second feedbelt assembly comprising a belt wound around a plurality of pulleys tocreate a multiple segmented belt, the multiple segmented belt configuredto contact the first feed belt assembly while providing clearance for aportion of the elongate member support extending between the belts ofthe first feed belt assembly. In one or more of the embodimentsdescribed herein, the first and second rotary members and the elongatemember support may be arranged such that the elongate member can be heldbetween the first and second rotary members while being supported by theelongate member support. Also, in one or more of the embodimentsdescribed herein, the elongate member support may have one or moreprotrusions with grooves, wherein the grooves may be configured to holdthe elongate member to prevent buckling of the elongate member duringrotational or linear motion of the elongate member, and the protrusionsmay be positioned within the spacing between the belts.

In some embodiments, the manipulator may include a roll supportconfigured to position the elongate member so that a bend at theelongate member faces towards a first direction, and to position theelongate member so that the bend faces towards a second direction thatis opposite from the first direction. In one or more of the embodimentsdescribed herein, the roll support may include a scissor jack. Also, insome embodiments, the manipulator may include a force sensor to measureforce at a distal tip of the elongate member. In other embodiments, themanipulator may include one or more slip rollers for gripping theelongate member, wherein the slip rollers may be decoupled from therotary members to detect sliding or slipping of the elongate memberbetween the rotary members. In further embodiments, the manipulator mayinclude a controller including a master input device, and an instrumentdriver in communication with the controller, the instrument driverconfigured to interface with a guide member and a sheath member.

In some embodiments, an elongate member manipulator may be implementedas a part of a robotic system. For example, in accordance with someembodiments, a robotic surgical system includes a controller including amaster input device, an instrument driver in communication with thecontroller, the instrument driver configured to interface with an innertubular member and an outer tubular member that surrounds at least aportion of the inner tubular member, and an elongate member manipulatorcomprising a drive assembly responsive to control signals generated, atleast in part, by the master input device, and an elongate member holderreleasably coupled to the drive assembly, the elongate member holderhaving first and second rotary members configured to hold an elongatemember, wherein the drive assembly is configured to actuate the rotarymembers in opposite rotational directions to generate a correspondinglinear motion of the elongate member along a longitudinal axis of theelongate member, wherein the drive assembly is configured to actuatesaid rotary members in opposite linear directions to generate acorresponding rotational motion of the elongate member about thelongitudinal axis of the elongate member, and wherein the elongatemember manipulator is configured to feed the elongate member into theinner tubular member. In some embodiments, the system may optionallyfurther include a sterile barrier positioned between the drive assemblyand the elongate member holder, wherein the drive assembly may beconfigured to transfer rotational motion across the sterile barrier tothe rotary members to generate the corresponding linear motion of theelongate member along the longitudinal axis of the elongate member.Also, in some embodiments, the system may include a sterile barrierpositioned between the drive assembly and the elongate member holder,wherein the drive assembly may transfer linear motion across the sterilebarrier to the rotary members to generate the corresponding rotationalmotion of the elongate member about the longitudinal axis of theelongate member.

In some embodiments, the drive assembly may be configured to actuate therotary members in rotational and linear directions simultaneously. Also,in some embodiments, the rotary members may be actuated in therotational and linear directions at different respective rates. In oneor more of the embodiments described herein, the drive assembly may beconfigured to provide rotational actuation and linear actuation for therotary members separately, and wherein the rotary members may beconfigured to maintain engagement with the elongate member between therotational actuation and linear actuation of the rotary members. In someembodiments, the elongate member may include a guide wire. Also, in someembodiments, the first and second rotary members may include first andsecond feed rollers. In one or more of the embodiments described herein,the first feed roller may have a groove cut around an outer diameter ofthe first feed roller, wherein the groove may be configured forreceiving an elongate member. Also, in one or more of the embodimentsdescribed herein, the first feed roller may be motor driven and thesecond feed roller may be idle. In addition, in one or more of theembodiments described herein, the first rotary member may include afirst flexible member with a first engagement surface, and the secondrotary member may include a second flexible member with a secondengagement surface. In other embodiments, the first flexible member maybe motor driven and the second flexible member may be idle. In furtherembodiments, the system may include an elongate member supportconfigured to hold the elongate member and to prevent buckling of theelongate member during rotational or linear motion of the elongatemember. In still further embodiments, the rotary members may include afirst rotary member and a second rotary member, and wherein the firstrotary member comprises a first feed belt assembly comprising two ormore belts with spacing between the belts to accommodate at least aportion of the elongate member support.

In some embodiments, the second rotary member may include a second feedbelt assembly comprising a belt wound around a plurality of pulleys tocreate a multiple segmented belt, the multiple segmented belt configuredto contact the first feed belt assembly while providing clearance for aportion of the elongate member support extending between the belts ofthe first feed belt assembly. Also, in some embodiments, the first andsecond rotary members and the elongate member support may be arrangedsuch that the elongate member can be held between the first and secondrotary members while being supported by the elongate member support. Inone or more of the embodiments described herein, the elongate membersupport may have one or more protrusions with grooves, wherein thegrooves are configured to hold the elongate member to prevent bucklingof the elongate member during rotational or linear motion of theelongate member, and the protrusions are positioned within the spacingbetween the belts. In further embodiments, the system may optionallyfurther include a roll support configured to position the elongatemember so that a bend at the elongate member faces towards a firstdirection, and to position the elongate member so that the bend facestowards a second direction that is opposite from the first direction. Inone or more of the embodiments described herein, the roll support mayinclude a scissor jack. Also, in some embodiments, the system mayinclude a force sensor to measure force at a distal tip of the elongatemember. In further embodiments, the system may include one or more sliprollers for gripping the elongate member, wherein the slip rollers aredecoupled from the rotary members to detect sliding or slipping of theelongate member between the rotary members.

Various methods for manipulating an elongate member are provided. Forexample, in accordance with some embodiments, a method of manipulatingan elongate member in two degrees of freedom includes holding anelongate member between two rotary members, actuating the rotary membersin opposite rotational directions to generate a corresponding linearmotion of the elongate member along a longitudinal axis of the elongatemember, and actuating the rotary members in opposite linear directionsto generate a corresponding rotational motion of the elongate memberabout the longitudinal axis of the elongate member. In some embodiments,the rotary members may include feed belts. Also, in some embodiments,the acts of actuating may be performed simultaneously. In otherembodiments, the acts of actuating may be performed at differentrespective rates. In still further embodiments, the acts of actuatingmay be performed separately, and wherein between the acts or actuating,the rotary members maintain engagement with the elongate member. In someembodiments, the method may optionally further include loading anelongate member by separating the two rotary members, and placing theelongate member on a surface of one of the two rotary members. Also, inone or more of the embodiments described herein, the method may includeremoving the elongate member from the first and second rotary memberswhile maintaining the elongate member in a patient's anatomy.

Other methods for manipulating an elongate member are also provided. Forexample, in accordance with other embodiments, a method of manipulatingan elongate member in two degrees of freedom includes transferringrotational motion across a sterile barrier to generate a correspondinglinear motion of the elongate member along a longitudinal axis of theelongate member, and transferring linear motion across the sterilebarrier to generate a corresponding rotational motion of the elongatemember about the longitudinal axis of the elongate member. In someembodiments, the rotational motion and the linear motion may betransferred simultaneously. Also, in some embodiments, the rotationalmotion and linear motion may be transferred at different respectiverates. In one or more of the embodiments described herein, therotational motion and the linear motion may be transferred separately,and wherein between the acts of transferring, the elongate member may bemaintained in engagement with rotary members.

In accordance with other embodiments, a method of manipulating anelongate member in two degrees of freedom includes engaging a firstcontinuous surface with the elongate member, engaging a secondcontinuous surface with the elongate member, actuating the first surfaceand second surface in opposite linear directions to generate arotational motion of the elongate member about the longitudinal axis ofthe elongate member, and actuating the first surface and second surfacein opposite rotational directions to generate a linear motion of theelongate member along the longitudinal axis of the elongate member. Insome embodiments, the rotational motion and the linear motion may begenerated simultaneously. Also, in some embodiments, the rotationalmotion and the linear motion may be generated at different respectiverates. In one or more of the embodiments described herein, therotational motion and the linear motion may be generated separately, andwherein the first and second continuous surfaces maintain engagementwith the elongate member between the generation of the rotational motionand the linear motion.

The robotic system may also optionally include a user interface forallowing a user to operate the robotic system in accordance with someembodiments. The user interface may provide a variety of features. Bymeans of non-limiting examples, the user interface may allow a user toalign a representation of a catheter with an image of the catheter in ascreen in some embodiments. In other embodiments, the user interface mayprovide a graphic for informing a user a constraint that is imposed bythe system on manipulating the elongate instrument.

In some embodiments, the user interface may be implemented using aprocessor. For example, in accordance with some embodiments, a systemincludes a processor configured for generating a virtual representationof a catheter on a viewing screen, a first control for allowing a userto rotate the virtual representation of the catheter about a first axis,until a heading direction of the virtual representation of the catheteraligns with a heading direction of the catheter as it appears in a firstfluoroscopic image, and a second control for allowing the user to rotatethe virtual representation of the catheter about a second axis, until atilt angle of the virtual representation of the catheter aligns with atilt angle of the catheter as it appears in the first fluoroscopic imageor in a second fluoroscopic image. In some embodiments, the firstcontrol may include a first slider in a touchscreen. Also, in someembodiments, the second control may include a second slider in thetouchscreen. In other embodiments, the first control may include atrackball. In one or more of the embodiments described herein, the firstcontrol may be configured for rotating the virtual representation of thecatheter about the first axis in a plane of the screen. In someembodiments, the system may also include an actuator coupled to thecatheter and configured for bending the catheter, and a third controlcoupled to the actuator for allowing the user to move the bent catheterinto alignment with a roll of the virtual representation of thecatheter. In one or more of the embodiments described herein, the systemmay include a third control for allowing the user to move the virtualrepresentation of the catheter into alignment with a roll of thecatheter. Also, in one or more of the embodiments described herein, thecatheter may have a bent configuration.

In some embodiments, the processor may be configured for generating thevirtual representation of the catheter using kinematic informationregarding the catheter. In one or more of the embodiments describedherein, the processor may be configured for generating the virtualrepresentation of the catheter based at least in part on a signaltransmitted through a fiber optic that extends along a length of thecatheter. In one or more of the embodiments described herein, theprocessor may be configured for generating the virtual representation ofthe catheter based at least in part on localization data obtained fromelectromagnetic sensors.

In some embodiments, a method may be implemented using a user interfacethat allows a user to align a representation of an elongate device withan image of an elongate device. For example, in accordance with someembodiments, a method includes generating a virtual representation ofthe catheter on a viewing screen, providing a first control for allowinga user to rotate the virtual representation of the catheter about afirst axis, until a heading direction of the virtual representation ofthe catheter aligns with a heading direction of the catheter as itappears in a first fluoroscopic image, and providing a second controlfor allowing the user to rotate the virtual representation of thecatheter about a second axis, until a tilt angle of the virtualrepresentation of the catheter aligns with a tilt angle of the catheteras it appears in the first fluoroscopic image or in a secondfluoroscopic image. In some embodiments, the first control may include afirst slider in a touchscreen. Also, in some embodiments, the secondcontrol may include a second slider in the touchscreen. In otherembodiments, the first control may include a trackball. In someembodiments, the virtual representation may be generated using kinematicinformation regarding the catheter. In other embodiments, the virtualrepresentation may be generated based at least in part on a signaltransmitted through a fiber optic that extends along a length of thecatheter. In one or more of the embodiments described herein, the firstcontrol may be provided for rotating the virtual representation of thecatheter about the first axis in a plane of the screen. Also, in one ormore of the embodiments described herein, the method may includeproviding a third control coupled to an actuator configured for movingthe catheter for allowing the user to move the catheter until theappearance of the catheter in the first or second fluoroscopic image isin alignment with a roll of the virtual representation of the catheter.In other embodiments, the method may include providing a third controlfor allowing the user to move the virtual representation of the catheterinto alignment with a roll of the catheter as it appears in the first orsecond fluoroscopic image. In one or more of the embodiments describedherein, the catheter may have a bent configuration.

In accordance with other embodiments, a computer product includes anon-transitory medium storing a set of instructions, an execution ofwhich causes a method for registering an image of a catheter with avirtual representation of the catheter to be performed, the set ofinstructions comprising one or more instructions for generating avirtual representation of the catheter on a viewing screen, one or moreinstructions for allowing a user to manipulate a first control to rotatethe virtual representation of the catheter about a first axis, until aheading direction of the virtual representation of the catheter alignswith a heading direction of the catheter as it appears in a firstfluoroscopic image, and one or more instructions for allowing the userto manipulate a second control to rotate the virtual representation ofthe catheter about a second axis, until a tilt angle of the virtualrepresentation of the catheter aligns with a tilt angle of the catheteras it appears in the first fluoroscopic image or in a secondfluoroscopic image. In some embodiments, the first control may include afirst slider in a touchscreen. Also, in some embodiments, the secondcontrol may include a second slider in the touchscreen. In otherembodiments, the first control may include a trackball. In one or moreof the embodiments described herein, manipulation of the first controlmay allow the user to rotate the virtual representation of the catheterabout the first axis in a plane of the screen. Also, in one or more ofthe embodiments described herein, the set of instructions may furtherinclude one or more instructions for allowing the user to manipulate athird control for moving the catheter, until the catheter as it appearsin the first or second fluoroscopic image is in alignment with a roll ofthe virtual representation of the catheter. In one or more of theembodiments described herein, the set of instructions may furtherinclude one or more instructions for allowing the user to manipulate athird control for moving the virtual representation of the catheter intoalignment with a roll of the catheter as it appears in the first orsecond fluoroscopic image. In some embodiments, the one or moreinstructions for generating the virtual representation may include oneor more instructions for using kinematic information regarding thecatheter to generate the virtual representation. In other embodiments,the one or more instructions for generating the virtual representationmay include one or more instructions for generating the virtualrepresentation based at least in part on a signal transmitted through afiber optic that extends along a length of the catheter. In one or moreof the embodiments described herein, the catheter may have a bentconfiguration.

In accordance with other embodiments, a user interface for controlling arobotic system includes a screen displaying an image of a catheter and adome at a distal end of the catheter, wherein the dome represents aconstraint for the distal end of the catheter so that at least a part ofthe distal end of the catheter is required to be on an outline of thedome regardless of how the catheter is driven. By means of non-limitingexamples, the dome may have a cardiod shape, a spherical shape, or anyshape that is user defined/computer calculated. In some embodiments, theuser interface may include a first control for allowing the user toadvance or retrace the catheter, and a second control for allowing theuser to steer the catheter. Also, in some embodiments, advancement orretraction of the catheter may change a size of the dome in the screen.In further embodiments, a steering of the catheter may not change a sizeof the dome in the screen. In one or more of the embodiments describedherein, the user interface may include a user control configured toprovide force feedback to a user. Also, in one or more of theembodiments described herein, the user control may be configured toprovide force feedback when the user attempts to position the at least apart of the distal end of the catheter away from the outline of thedome. In some embodiments, the image of the catheter may include acomputer model of the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments, in whichsimilar elements are referred to by common reference numerals. Thesedrawings are not necessarily drawn to scale. In order to betterappreciate how the above-recited and other advantages and objects areobtained, a more particular description of the embodiments will berendered, which are illustrated in the accompanying drawings. Thesedrawings depict only typical embodiments and are not therefore to beconsidered limiting of its scope.

FIG. 1 illustrates a robotic surgical system in which apparatus, systemand method embodiments may be implemented.

FIG. 2 illustrates an example of an operator workstation of the roboticsurgical system shown in FIG. 1 with which a catheter instrument can bemanipulated using different user interfaces and controls.

FIG. 3A illustrates a support assembly or mounting brace for ainstrument driver of a robotic surgical system.

FIG. 3B further illustrates the support assembly illustrated in FIG. 3A.

FIG. 3C is another view of the support assembly shown in FIGS. 3A-B withan attached instrument driver.

FIG. 3D is a perspective view of a support arm adapter base plateassembly configured for attaching a support assembly to an operatingtable or surgical bed.

FIG. 3E further illustrates how the adapter base plate assembly isutilized to attach a support assembly and instrument driver to anoperating table or surgical bed.

FIG. 4 illustrates an instrument driver mounted to a distal segment of asupport assembly.

FIG. 5A illustrates a sheath and guide catheter assembly mounted on aninstrument driver.

FIG. 5B further illustrates the instrument driver shown in FIG. 5Awithout the sheath and guide catheter assembly.

FIG. 5C further illustrates the instrument driver shown in FIG. 5B withskins removed and one of the mounting plates being moved relative to themounting plate arrangement shown in FIG. 5B.

FIG. 6A illustrates a sheath and guide catheter assembly positioned overrespective mounting plates.

FIG. 6B further illustrates how sheath and guide splayers interface withrespective mounting plates.

FIG. 7 illustrates an exploded view of the sheath splayer shown in FIG.6B without a purge tube.

FIG. 7A illustrates a pulley assembly of the splayer shown in FIG. 7.

FIG. 7B illustrates an exploded view of the pulley assembly shown inFIG. 7A.

FIG. 7C illustrates the top portion of the pulley assembly shown in FIG.7A.

FIG. 7D illustrates the bottom portion of the pulley assembly shown inFIG. 7A.

FIG. 7E illustrates a bottom perspective view of a cover of the splayershown in FIG. 7.

FIG. 7F illustrates an exploded view of a splayer base assembly of thesplayer shown in FIG. 7.

FIG. 8A illustrates a guide carriage of the instrument driver shown inFIG. 5C coupled to cabling and guide motors.

FIG. 8B is a perspective view of a slidable carriage or funicularassembly of an instrument driver and receiver slots configured toreceive and engage with splayer shafts.

FIG. 9A is a perspective view of a drive shaft positioned for insertioninto a sleeve receptacle located on an instrument driver.

FIG. 9B of a drive shaft that is inserted into a sleeve receptacle.

FIG. 10 illustrates a sheath block and guide insert motor and leadscrewremoved from the instrument driver shown in FIG. 5C.

FIGS. 10A and 10B illustrate different perspective views of the sheathblock.

FIGS. 11A-11H illustrate side and cross-sectional views of a catheterbent in various configurations with pull wire manipulation.

FIG. 12 shows an example of an overview block diagram of a basictopology for controlling flexible devices.

FIG. 13 illustrates forward kinematics and inverse kinematics inaccordance with some embodiments.

FIG. 14 illustrates task coordinates, joint coordinates, and actuationcoordinates in accordance with some embodiments.

FIG. 15 illustrates variables associated with a geometry of a catheterin accordance with some embodiments.

FIG. 16 illustrates a conventional open loop control model.

FIG. 17 illustrates a control system in accordance with someembodiments.

FIG. 18 illustrates a user interface for a master input device.

FIGS. 19-29 illustrate software control schema in accordance withvarious embodiments.

FIG. 30 illustrates a distal portion of a guide catheter extendingbeyond a distal end of a sheath instrument by a distance or length L₁and a force F imparted on the distal tip of the guide catheter that maycause the distal portion of the guide catheter to bend or flex.

FIG. 31 illustrates a distal portion of a guide catheter extendingbeyond a distal end of a sheath instrument by a distance or length L₂that is less than the length L₁ shown in FIG. 30.

FIG. 32 illustrates assessing reachability and viewability or field ofview according to one embodiment.

FIG. 33A illustrates a cross-sectional view of a flexible and steerableelongate instrument with variable or changeable shape control andsupport elements in accordance with one embodiment.

FIG. 33B illustrates another cross-sectional view (View 1-1) of aflexible and steerable elongate instrument with variable or changeableshape control and support elements in accordance with one embodiment.

FIG. 34A illustrates an elongate instrument with passively controlledflex member in accordance with one embodiment.

FIG. 34B illustrates a passively controlled flex member with a serviceor buffer loop in accordance with one embodiment.

FIG. 34C illustrates support tubes or support members sliding along theflex tubes or flex members in accordance with one embodiment.

FIG. 34D illustrates slidable couplings of variable shape control andsupport components near the proximal section of a flexible and steerableelongate instrument in accordance with one embodiment.

FIGS. 35A-35C illustrate the operation of a substantially flexible andsteerable elongate instrument in accordance with one embodiment.

FIG. 36A and FIG. 36B illustrate curve aligned steering of a flexibleand steerable elongate instrument in accordance with one embodiment.

FIG. 36C illustrates an embodiment of an elongate instrument that doesnot have coil pipes.

FIG. 36D illustrates a mechanics of a coil pipe in accordance with someembodiments.

FIGS. 37A-37E illustrate another catheter in accordance with otherembodiments.

FIGS. 38-44 illustrate a sheath in accordance with some embodiments, andvariations thereof.

FIGS. 45-48 illustrate methods of using a catheter and a sheath inaccordance with different embodiments.

FIGS. 49-50C illustrate a valve in accordance with some embodiments.

FIGS. 51A-51F illustrate another robotic surgical system 400 inaccordance with other embodiments.

FIG. 51G illustrates a rail system configured to tilt a setup mount inaccordance with some embodiments.

FIG. 52A illustrates driving mode(s) in accordance with someembodiments.

FIG. 52B illustrates driving mode(s) in accordance with otherembodiments.

FIG. 52C illustrates driving mode(s) in accordance with otherembodiments.

FIG. 52D illustrates driving mode(s) in accordance with otherembodiments.

FIGS. 53A-67C illustrate different anti-buckling devices, and componentsthat operate with the anti-buckling devices, in accordance withdifferent embodiments; and

FIGS. 68-78A illustrate different lubricating mechanisms in accordancewith different embodiments.

FIG. 79A illustrates a front perspective view of a variation of anelongate member manipulator.

FIG. 79B illustrates an end perspective view of the elongate membermanipulator of FIG. 79A.

FIG. 79C illustrates a cross sectional view of the elongate membermanipulator of FIG. 79A.

FIG. 79D illustrates a top cross sectional view of the elongate membermanipulator of FIG. 79A.

FIGS. 80A-80B are schematic illustrations showing top and front views offeed rollers actuating an elongate member.

FIG. 81 illustrates a cross sectional view of one variation of a rolleractuator.

FIG. 82 illustrates a cross sectional view of one variation of a feedroller with a drape, [00134] FIG. 83 illustrates a perspective view ofthe instrument driver, the guide splayer and a variation of an elongatemember manipulator.

FIG. 83A illustrates a closer view of the instrument driver, theelongate member manipulator, and the guide splayer of FIG. 83.

FIG. 84 illustrates a perspective view of the elongate membermanipulator of FIG. 83, showing the manipulator in an open configurationand mounted to a manipulator mounting bracket.

FIG. 85A illustrates the elongate member manipulator of FIG. 84, showingthe manipulator in a closed configuration.

FIGS. 85B-85C illustrate the elongate member manipulator of FIG. 84 withan idler belt assembly removed, showing the manipulator open by varyingdegrees.

FIG. 85D illustrates the elongate member manipulator of FIG. 85B in aclosed configuration.

FIG. 85E illustrates a cross-sectional view of the elongate membermanipulator of FIG. 85A.

FIG. 86A illustrates a back view of the elongate member manipulator ofFIG. 84.

FIGS. 86B-86C illustrates various perspective views of the elongatemember manipulator of FIG. 85.

FIG. 87A illustrates a side view of the elongate member manipulator ofFIG. 85, showing a hinge mechanism in a closed configuration.

FIG. 87B illustrates the elongate member manipulator of FIG. 87A,showing the hinge mechanism in an open configuration.

FIG. 87C illustrates a cross sectional perspective view of the elongatemember manipulator of FIG. 84.

FIG. 88 illustrates a perspective view of the elongate membermanipulator of FIG. 84 with wire holders installed, showing both themanipulator and wire holders in open configurations.

FIG. 89 illustrates the elongate member manipulator of FIG. 88, showingthe manipulator and wire holders in closed configurations.

FIG. 90A illustrates an exploded perspective view of the elongate membermanipulator of FIG. 84, showing the idler belt assembly and a drive beltassembly partially removed.

FIG. 90B illustrates a cross sectional view of the elongate membermanipulator of FIG. 84, showing the idler belt assembly and the drivebelt assembly partially un-installed.

FIG. 90C illustrates a cross sectional view of the elongate membermanipulator of FIG. 84, showing the idler belt assembly and the drivebelt assembly fully installed.

FIGS. 91A-91C illustrate perspective views of the instrument driver, theguide splayer and another alternative variation of an elongate membermanipulator.

FIGS. 91D-91E illustrate perspective views of the elongate membermanipulator of FIG. 91A.

FIG. 91F illustrates a perspective view of the elongate membermanipulator of FIG. 91A, showing the elongate member manipulator in anopen configuration.

FIG. 91G illustrates a side view of the elongate member manipulator ofFIG. 91A, showing the manipulator mounting bracket, a roll motor, and aninsert motor all removed.

FIG. 91H illustrates a cross sectional side view of the elongate memberFIG. 91A, showing the manipulator mounting bracket, the roll motor, andthe insert motor all removed.

FIGS. 92A-92B illustrate perspective views of an idler belt assembly ofthe elongate member manipulator of FIG. 91A.

FIGS. 93A-93D illustrate various perspective views of a drive beltassembly of the elongate member manipulator of FIG. 91A.

FIG. 94A illustrates a perspective view of an elongate member support ofthe elongate member manipulator of FIG. 91A.

FIG. 94B illustrates a cross sectional top view of the elongate membersupport of FIG. 94A.

FIG. 94C illustrates an alternative perspective view of the elongatemember manipulator of FIG. 91A, showing the manipulator mounted to amanipulator mounting bracket.

FIG. 94D illustrates the elongate member manipulator of FIG. 94C,showing an insert motor cover removed.

FIG. 94E illustrates a zoomed in view of the insert motor of theelongate member manipulator of FIG. 94D.

FIG. 95A illustrates a perspective view of a valve holder of theelongate member manipulator of FIG. 91A, showing the valve holder in aclosed configuration.

FIGS. 95B-95C illustrate various perspective views of the valve holderof FIG. 95A in an open configuration.

FIGS. 95D-95E illustrate front and back perspective views of a valveassembly of the elongate member manipulator of FIG. 91A, showing asupport tube and guide wire installed.

FIG. 95F illustrates an exploded perspective view of the valve assemblyof FIG. 95D, showing the support tube and guide wire removed.

FIG. 96 illustrates the drive belt assembly and idler belt assembly ofFIG. 91A, showing a portion of the drape.

FIG. 96A illustrates a cross sectional bottom view of the drive beltassembly of FIG. 94A.

FIG. 96B illustrates a cross sectional bottom view of the idler beltassembly of FIG. 92A.

FIG. 96C illustrates a perspective view of a representation of analternative elongate member manipulator with a guide wire installed.

FIGS. 96D-96E illustrate side views of the elongate member manipulatorof FIG. 96C showing roll actuation of the guide wire.

FIG. 97 illustrates a perspective view of another variation of anelongate member manipulator mounted to a variation of an instrumentdriver.

FIGS. 97 aa-97 ab illustrate various views of the elongate membermanipulator of FIG. 97 with a cover removed.

FIGS. 97A1-97A2 illustrate a front view of the elongate membermanipulator of FIG. 97 in an closed and open configuration respectively.

FIGS. 97A3-97A4 illustrate a back view of the elongate membermanipulator of FIG. 97 in an closed and open configuration respectively.

FIGS. 97B1-97B2 illustrate front and back perspective views of theelongate member manipulator of FIG. 97A1 with the cover removed.

FIG. 97B3 illustrates a zoomed in view of a roll motor and accompanyingroll mechanisms.

FIG. 97C illustrates the elongate member manipulator of FIGS. 97B1-97B2with only insert mechanical components and a drive belt assemblydisplayed.

FIG. 97D1 illustrates a perspective view of the drive belt assembly ofFIG. 97C.

FIG. 97D2 illustrates a cross sectional view of the drive belt assemblyof FIG. 97D1.

FIG. 97D3 illustrates a zoomed in view of a drive shaft shown in FIG.97D2.

FIGS. 97E1-E2 illustrate upper and lower slide assemblies of theelongate member manipulator of FIG. 97C with the drive belt assembly andan idler belt assembly installed and un-installed respectively.

FIG. 97F illustrates an exploded view of the upper slide assembly ofFIGS. 97E1-97E2.

FIG. 97G illustrates a top, front and side view of a simplifiedrepresentation of an alignment bar and cradle of the upper slideassembly shown in FIG. 97F.

FIG. 97H1 illustrates the elongate member manipulator of FIG. 97A1 withthe drive and idler belt assemblies removed.

FIG. 97H2 illustrates a view of the elongate member manipulator of FIG.97H1 with an elongate member holder exploded from the elongate membermanipulator.

FIG. 97J1 illustrates the elongate member holder of FIGS. 97H1-97H2 witha guide wire and valve installed.

FIG. 97J2 illustrates the elongate member holder of FIG. 97J1 with avalve holder in an open configuration and the guide wire and valveexploded from the elongate member holder.

FIGS. 97J3-97J4 illustrate different perspective views of the valveholder of FIGS. 97J1-97J2 in closed and open configurationsrespectively.

FIGS. 97K1 and K2 illustrate perspective views of a drape assembly.

FIGS. 97L1-97L2 illustrate top and bottom perspective views of a tentingframe of the drape assembly shown in FIGS. 97K1-97K2.

FIGS. 97M1-97M5 illustrate the drape assembly of FIG. 97K beinginstalled on a simplified model of the elongate member manipulator ofFIG. 97A1.

FIGS. 97M6-97M7 illustrate the drape installed on the elongate membermanipulator of FIG. 97A1 in a closed and open configurationrespectively.

FIG. 98A illustrates a perspective view of an instrument driver with aguide splayer and another variation of an elongate member manipulator.

FIG. 98B illustrates a closer view of the instrument driver, guidesplayer, and elongate member manipulator of FIG. 98A.

FIG. 99 illustrates a perspective view of the elongate membermanipulator of FIG. 98A.

FIGS. 100A-100B illustrate perspective views of the elongate membermanipulator of FIG. 99, showing a motor pack cover removed.

FIGS. 101A-101B illustrate front and back perspective views of a beltassembly of the elongate member manipulator of FIG. 99.

FIG. 101C illustrates a back view of the belt assembly of FIG. 101A.

FIG. 102A illustrates a side view of the belt assembly of FIG. 101A.

FIG. 102B illustrates the belt assembly of FIG. 102A, shown in an openconfiguration.

FIG. 103 illustrates a perspective view of the instrument driver, guidesplayer, and an alternative variation of an elongate member manipulator,showing the manipulator un-installed.

FIGS. 103AA-103AB illustrate perspective and side views of an adaptedTiny-Vise clamp.

FIG. 103A illustrates a top view of the elongate member manipulator ofFIG. 103, showing a guide wire and a roll support tube.

FIG. 103B illustrates a top view of the elongate member manipulator ofFIG. 103, showing a guide wire and a scissor jack support.

FIG. 104 illustrates a perspective view of the elongate membermanipulator of FIG. 103, showing a motor pack cover removed.

FIG. 105 illustrates a perspective view of a feed roller assembly of theelongate member manipulator of FIG. 104.

FIG. 106A illustrates a closer view of the feed roller assembly of FIG.105.

FIGS. 106B-107A illustrate a top view of the feed roller assembly ofFIG. 105.

FIG. 107B illustrates a bottom view of the feed roller assembly of FIG.105.

FIG. 108A illustrates a representation of the bottom view of a geartrain of the feed roller assembly of FIG. 105.

FIG. 108B illustrates the gear train representation of FIG. 108A,showing the gear train pivoted in an open configuration.

FIG. 109 illustrates a side view of a drive roller and feed roller ofFIG. 105, showing a guide wire installed.

FIG. 110A illustrates a top view of the feed roller assembly of FIG.105, showing an insert assembly removed from an actuation assembly.

FIG. 110B illustrates a perspective view of the feed roller assembly.

FIGS. 111A-111F illustrate top views of simplified representations ofvarious feed roller and feed belt combinations.

FIG. 112A illustrates a bottom perspective view of the elongate membermanipulator of FIG. 85.

FIG. 112B illustrates a bottom perspective view of the elongate membermanipulator of FIG. 104.

FIG. 113 illustrates a top view of a variation of a control console ofthe operator workstation of FIG. 1.

FIG. 114A illustrates a perspective view of a patient bed of the roboticinstrument system of FIG. 1, showing a standalone console mounted to thepatient bed.

FIG. 114B illustrates a side view of the standalone console of FIG.114A, showing the standalone console mounted to a mounting bracket and abed rail.

FIG. 115 illustrates a top view of a variation of the standalone consoleof FIG. 114A.

FIGS. 116 and 117A-117M illustrate variations of a master input device.

FIGS. 118A-D illustrate flow diagrams of various master-slave controloptions.

FIG. 119 illustrates a perspective view of the instrument driver and theelongate member manipulator of FIG. 91A with an anti-buckling mechanisminstalled.

FIG. 120 illustrates a flow diagram of a variation of a control schemefor control of the elongate member manipulator of FIGS. 79A, 85, 91A,99, 103A, or 124A.

FIGS. 121A-121B illustrate block diagrams representing the instrumentdriver, the elongate member manipulator, the guide catheter, and thesheath catheter.

FIG. 122 illustrates a flow diagram of the controller for theconfiguration with a movable carriage and a coupled elongate membermanipulator of FIG. 121B.

FIG. 123 illustrates a representation of a variation of a virtual guidewire.

FIG. 124A illustrates a perspective view of another alternativevariation of an elongate member manipulator.

FIGS. 124B-C illustrates perspective views of the elongate membermanipulator of FIG. 124A, showing the manipulator cover removed.

FIGS. 125A and 127A illustrate a perspective views of a rotation driveof the elongate member manipulator of FIG. 124C.

FIG. 125B illustrates a side perspective view of the rotation drive ofFIG. 125A with the guide wire installed.

FIG. 125C illustrates a closer perspective view of the rotation drive ofFIG. 125A.

FIG. 126 illustrates a side cross sectional view of the elongate membermanipulator of FIG. 124B.

FIG. 127B illustrates a side cross sectional view of the rotation driveof FIG. 125A.

FIG. 127C illustrates a side and a cross sectional view of the rotationdrive of FIG. 125A.

FIG. 128A illustrates a control system in accordance with someembodiments.

FIG. 128B illustrates a localization sensing system having anelectromagnetic field receiver in accordance with some embodiments.

FIG. 128C illustrates a localization sensing system in accordance withother embodiments.

FIG. 128D illustrates a user interface for a master input device inaccordance with some embodiments.

FIG. 128E illustrates a configuration of a catheter in accordance withsome embodiments.

FIG. 128F illustrates another configuration of a catheter in accordancewith other embodiments.

FIG. 128G illustrates a catheter that is haptically constrained to asurface of a “dome” in accordance with some embodiments.

FIG. 129a is a perspective view of an instrument driver with a sheathand guide splayer installed.

FIG. 129b is a zoomed in view of the sheath splayer mounted to theinstrument driver of FIG. 129 a.

FIG. 129c is an exploded view of the sheath splayer and instrumentdriver of FIG. 129 b.

FIGS. 130a and 130b are top and bottom perspective view respectively ofa sheath output plate.

FIG. 130c is an exploded bottom perspective view of the sheath outputplate of FIG. 130 a.

FIGS. 131a and 131b are top and bottom perspective views respectively ofa base plate.

FIG. 131c is a perspective view of a guide output plate.

FIGS. 132a and 132b are top and bottom perspective views respectively ofa drive interface apparatus.

FIG. 132c is an exploded perspective view of the drive interfaceapparatus of FIG. 132 a.

FIGS. 133a and 133b are top perspective views respectively of a driveinterface base.

FIGS. 134a and 134b are top and bottom perspective view respectively ofthe drive interface base of FIG. 133a populated with a plurality ofdrive interface pulley shafts and a pair of EEPROM pins.

FIG. 135a is a perspective view of a drape assembly.

FIG. 135b is a zoomed in perspective view of a portion of the drapeassembly of FIG. 135a including a sheath foam pad.

FIG. 135c is a zoomed in perspective view of a portion of the drapeassembly of FIG. 135a including a guide foam pad.

FIG. 136a is a perspective view of a sheath splayer.

FIG. 136b is a perspective view of a guide splayer.

FIG. 136c is a perspective view of the sheath splayer of FIG. 136a witha splayer cover exploded from the sheath splayer.

FIGS. 137a and 137b are top and bottom perspective views respectively ofa splayer body.

FIG. 137c is an exploded perspective view of the splayer body of FIG.137 a.

FIG. 138 is a bottom view of a splayer cover.

FIGS. 138a and 138b are perspective and exploded views respectively of asplayer pulley assembly.

FIGS. 139a and 139b are top and bottom perspective views respectively ofa splayer base.

FIGS. 140a and 140b are top and bottom perspective views respectively ofthe splayer base of FIG. 139a populated with a plurality of splayerpulley assemblies, a splayer presence magnet, and a splayer ID chip.

FIGS. 141a and 141b illustrate methods of installing the drape assemblyof FIG. 135a over the instrument driver.

FIG. 142a is a perspective view of the instrument assembly with thedrape assembly installed and the drive interface apparatus exploded fromthe instrument driver.

FIG. 142b is a perspective view of the instrument assembly and drapeassembly of FIG. 142a with the drive interface apparatus installed.

FIG. 143a is a top perspective view of the sheath output plate with thedrape assembly installed and the drive interface apparatus exploded.

FIG. 143b is a bottom perspective view of the sheath output plate, drapeassembly, and drive interface apparatus of FIG. 143 a.

FIG. 143c is a bottom perspective view of the sheath output plate withthe drape and drive interface apparatus installed.

FIGS. 144a and 144b are perspective views of a drive interface pulleyshaft installed and uninstalled respectively to a sleeve receptacle.

FIGS. 144c and 144d are side and front views of the drive interfacepulley and sleeve receptacle illustrated in FIG. 144 b.

FIGS. 145a and 145b are top and bottom perspective view of the sheathsplayer exploded from the drive interface apparatus.

FIG. 146a is a top view of the splayer pulley assembly.

FIG. 146b is a top view of the drive interface pulley shaft.

FIGS. 147a and 147b are top and bottom perspective views respectively ofthe splayer pulley assembly exploded from the drive interface pulleyshaft.

FIGS. 148a and 148b are top and bottom exploded views respectively ofthe instrument driver with the drape assembly installed and the driveinterface apparatus and sheath splayer un-installed.

DESCRIPTION OF THE EMBODIMENTS

Various embodiments are described hereinafter with reference to thefigures. It should be noted that the figures are not drawn to scale andthat elements of similar structures or functions are represented by likereference numerals throughout the figures. It should also be noted thatthe figures are only intended to facilitate the description of theembodiments. They are not intended as an exhaustive description of theinvention or as a limitation on the scope of the invention. In addition,an illustrated embodiment needs not have all the aspects or advantagesshown. An aspect or an advantage described in conjunction with aparticular embodiment is not necessarily limited to that embodiment andcan be practiced in any other embodiments even if not so illustrated.

I. Robotic Surgical Systems

Embodiments described herein generally relate to apparatus, systems andmethods for robotic surgical systems. A robotic surgical systems inwhich embodiments described herein may be implemented is described withreference to FIGS. 1-10B. Various embodiments of apparatus, system andmethod, including control and electronic architectures, are describedwith reference to FIGS. 11A-19K. Various embodiments directed toindicating catheter insertion forces as the catheter engages tissue oranother object are described with reference to FIGS. 20A-B. Variousembodiments directed to determining reachability of catheter instrumentand viewability or fields of view at different reachable locations aredescribed with reference to FIG. 21.

Referring to FIG. 1, a robotically controlled surgical system (S) inwhich embodiments of apparatus, system and method may be implementedincludes a robotic catheter assembly (A) having a first or outer roboticsteerable complement, otherwise referred to as a sheath instrument 30(generally referred to as “sheath” or “sheath instrument”) and/or asecond or inner steerable component, otherwise referred to as a roboticcatheter or guide or catheter instrument 18 (generally referred to as“catheter” or “catheter instrument”). The sheath instrument 30 andcatheter instrument 18 are controllable using a robotic instrumentdriver 16 (generally referred to as “instrument driver”). During use, apatient is positioned on an operating table or surgical bed 22(generally referred to as “operating table”) to which a robotic catheterassembly (A) is coupled or mounted. In the illustrated example, thesystem (S) includes an operator workstation 2, an electronics rack 6 andassociated bedside electronics box, a setup joint mounting brace 20, andan instrument driver 16. A surgeon is seated at the operator workstation2 and can monitor the surgical procedure, patient vitals, and controlone or more catheter devices.

Various system (S) components in which embodiments described herein maybe implemented are illustrated in close proximity to each other in FIG.1, but embodiments may also be implemented in systems (S) in whichcomponents are separated from each other, e.g., located in separaterooms. For example, the instrument driver 16, operating table 22, andbedside electronics box may be located in the surgical area with thepatient, and the operator workstation 2 and the electronics rack 6 maybe located outside of the surgical area and behind a shielded partition.System (S) components may also communicate with other system (S)components via a network to allow for remote surgical procedures duringwhich the surgeon may be located at a different location, e.g., in adifferent building or at a different hospital utilizing a communicationlink transfers signals between the operator control station 2 and theinstrument driver 16. System (S) components may also be coupled togethervia a plurality of cables or other suitable connectors 14 to provide fordata communication, or one or more components may be equipped withwireless communication components to reduce or eliminate cables 14. Inthis manner, a surgeon or other operator may control a surgicalinstrument while being located away from or remotely from radiationsources, thereby decreasing the operator's exposure to radiation.

Referring to FIG. 2, one example of an operator workstation 2 that maybe used with the system (S) shown in FIG. 1 includes three displayscreens 4, a touch screen user interface 5, a control button console orpendant 8, and a master input device (MID) 12. The MID 12 and pendant 8serve as user interfaces through which the surgeon can control operationof the instrument driver 16 and attached instruments. By manipulatingthe pendant 8 and the MID 12, a surgeon or other operator can cause theinstrument driver 16 to remotely control a catheter instrument 18 and/ora sheath instrument 30 mounted thereon. A switch 7 may be provided todisable activity of an instrument temporarily. The console 2 in theillustrated system (S) may also be configurable to meet individual userpreferences. For example, in the illustrated example, the pendant 8 andthe touch screen 5 are shown on the left side of the console 2, but theymay also be relocated to the right side of the console 2. Further,optional keyboard may be connected to the console 2 for inputting userdata. The workstation 2 may also be mounted on a set of casters orwheels to allow easy movement of the workstation 2 from one location toanother, e.g., within the operating room or catheter laboratory. Furtheraspects of examples of suitable MID 12, and workstation 2 arrangementsare described in further detail in U.S. patent application Ser. No.11/481,433, issued as U.S. Pat. No. 8,052,636 on Nov. 8, 2011, and U.S.Provisional Patent Application No. 60/840,331, the contents of whichwere previously incorporated herein by reference. Additional embodimentsof various MIDs and pendants will also be described later.

Referring to FIGS. 3A-C, a system (S) includes a setup joint or supportassembly 20 (generally referred to as “support assembly”) for supportingor carrying the instrument driver 16 over the operating table 22. Onesuitable support assembly 20 has an arcuate shape and is configured toposition the instrument driver 16 above a patient lying on the table 22.The support assembly 20 may be configured to movably support theinstrument driver 16 and to allow convenient access to a desiredlocation relative to the patient. The support assembly 20 may also beconfigured to lock the instrument driver 16 into a certain position.

In the illustrated example, the support assembly 20 is mounted to anedge of the operating table 22 such that a catheter and sheathinstruments 18, 30 mounted on the instrument driver 16 can be positionedfor insertion into a patient. The instrument driver 16 is controllableto maneuver the catheter and/or sheath instruments 18, 30 within thepatient during a surgical procedure. The distal portion of the setupjoint 20 also includes a control lever 33 for maneuvering the setupjoint 20. Although the figures illustrate a single guide catheter 18 andsheath assembly 30 mounted on a single instrument driver 16, embodimentsmay be implemented in systems (S) having other configurations. Forexample, embodiments may be implemented in systems (S) that include aplurality of instrument drivers 16 on which a plurality ofcatheter/sheath instruments 18, 30 can be controlled. Further aspects ofa suitable support assembly 20 are described in U.S. patent applicationSer. No. 11/481,433, issued as U.S. Pat. No. 8,052,636 on Nov. 8, 2011,and U.S. Provisional Patent Application No. 60/879,911, the contents ofwhich are expressly incorporated herein by reference. Referring to FIG.3D-E, the support assembly 20 may be mounted to an operating table 22using a universal adapter base plate assembly 39, similar to thosedescribed in detail in U.S. Provisional Patent Application No.60/899,048, incorporated by reference herein in its entirety. Theadapter plate assembly 39 mounts directly to the operating table 22using clamp assemblies 39 b, 39 c, and the support assembly 20 can bemounted to the adapter plate assembly 39. One suitable adapter plateassembly 39 includes a large, flat main plate 39 a which is positionedon top of the operating table 22. The assembly 39 provides for variousadjustments to allow it to be mounted to different types of operatingtables 22. An edge of the adapter plate assembly 39 may include a rail39 d that mimics the construction of a traditional surgical bedrail. Byplacing this rail on the adapter plate 39 a itself, a user may beassured that the component dimensions provide for proper mounting of thesupport assembly 20. Furthermore, the large, flat surface of the mainplate 39 a provides stability by distributing the weight of the supportassembly 20 and instrument driver 16 over an area of the table 22,whereas a support assembly 20 mounted directly to the operating table 22rail may cause its entire load to be placed on a limited and lesssupportive section of the table 22.

With further reference to FIGS. 4 and 5A, an instrument assembly (A)comprised of a sheath instrument 30 and an associated guide or catheterinstrument 18 is mounted to associated mounting plates 37, 38 on a topportion of the instrument driver 16. FIG. 5B illustrates the instrumentdriver 16 without an attached instrument assembly (A). FIG. 5Cillustrates the instrument driver 16 with skins removed to illustrateinternal components which will be described in further detail.Embodiments described are similar to those described in detail in U.S.patent application Ser. No. 11/678,001, issued as U.S. Pat. No.8,092,397 on Jan. 10, 2012; Ser. No. 11/678,016, issued as U.S. Pat. No.8,052,621 on Nov. 8, 2011; and Ser. No. 11/804,585, now abandoned, eachincorporated by reference herein in its entirety.

Referring to FIGS. 6A-B, the assembly (A) that includes a sheathinstrument 30 and a guide or catheter instrument 18 positioned overtheir respective mounting plates 38, 37 is illustrated removed from theinstrument driver 16. The guide catheter instrument member 61 a iscoaxially interfaced with the sheath instrument member 62 a by insertingthe guide catheter instrument member 61 a into a working lumen of thesheath catheter member 62 a. As shown in FIG. 6A, the sheath instrument30 and the guide or catheter instrument 18 are coaxially disposed formounting onto the instrument driver 16. However, it should be understoodthat a sheath instrument 16 is used without a guide or catheterinstrument 18, or a guide or catheter instrument 18 is used without asheath instrument 30 may be mounted onto the instrument driver 16individually. With the coaxial arrangement as shown in FIG. 6A, theguide catheter splayer 61 is located proximally relative to, or behind,the sheath splayer 62 such that the guide catheter member 61 a can beinserted into and removed from the sheath catheter member 61 b.

Examples of how sheath and guide splayers 62, 61 may be structured areshown in FIGS. 7-7F. FIG. 7 illustrates the sheath splayer 62 of oneembodiment illustrated without a purge tube 32. As shown in FIG. 6A, thesheath and guide splayers 62, 61, appear similar physically inconstruction with the exception that the guide splayer 62 includes thepurge tube 32. It should be noted that the purge tube 32 may or may notbe included for either the guide or sheath splayer. The sheath splayer62 will be described herein. However it should be understood that theguide splayer 61 is of similar construction, and components of thesheath splayer 62 can be repeated for the guide splayer 61.

As illustrated in FIG. 7, the splayer 62 includes a splayer cover 72fixably coupled to a splayer base assembly 78 using four screws 79. Thesplayer base 78 having four cavities to receive and house pulleyassemblies 80 is used for both the guide splayer 61 and sheath splayer62. For this embodiment of a sheath splayer 62, two cavities of thesplayer base 78 are populated with pulley assemblies 80 and theremaining cavities are left open. The guide splayer 61 may have all itscavities populated with four pulley assemblies 80, as can be seen inFIG. 6B. The splayer base 78 of this implementation can be constructedfrom injection molded polycarbonate.

One implementation uses substantially identical pulley assemblies 80 inboth the guide and sheath splayers 61,62 which are illustrated in FIGS.7A-D. FIG. 7A illustrates the full pulley assembly 80. FIG. 7Billustrates an exploded view of the pulley assembly 80. Each pulleyassembly 80 includes a top portion 82 and a bottom portion 84 heldtogether with four screws 86 and four washers 88. Note that in FIG. 7B,only two screws 86 and two washers 88 are shown for clarity. Referringto FIG. 7C, the top portion 82 of the pulley assembly 80 includes astainless steel insert mold or drive shaft 90 with a drive pin 90 b. Thedrive shaft 90 includes a flat portion 90 a allowing it to form aD-shaped cross section. The bottom portion 84 includes four tapped holes84 a to receive the ends of the four screws 86 and also a wire securingslot 84 b. As a pulley assembly 80 is put together and mated with acatheter pull wire or control element (not shown), the pull wire can besecured to the pulley assembly 80 by inserting the pull wire into thewire securing slot 84 b. The pull wire (not shown) runs down the lengthof a catheter from distal to proximal end then is wound about thepulley. By rotating the pulley, the pull wire bends the distal tip ofthe catheter controlling its bend. The kinematics of roboticallycontrolled catheters with pull wires will be described in further detailbelow.

FIG. 7E illustrates the splayer cover 72 of one embodiment. The splayercover 72 in this example includes a pair of latches 74 located on itsinner surface. These latches are designed to engage with correspondingnotches 38 b located on the mounting plates 38 illustrated in FIG. 6B.The splayer cover 72 also includes four holes 72 a to receive themounting screws 79 used to couple the splayer cover 72 to the splayerbase assembly 78. The splayer cover 72 and the latches 74 of thisembodiment can be ABS molded. A pair of urethane based compliant members82 located on the sides of the splayer cover 72 is over molded with thesplayer cover 72 such that the splayer cover 72 is results as a singlepiece. Along opposing sides on the inside of the splayer cover 72 inthis embodiment are two pairs of foam pads 84. Each pair of foam pads 84are located adjacent to the latch 74 and serve to provide its latch 74some spring tension wherein better engagement between the splayer cover72 and the mounting plate 38 can be achieved. In one implementation, auser can remove a splayer 62 mounted to an RCM by squeezing at thecompliant member 82, which in turn depress and disengage the latches 74from the notches 38 b of the RCM mounting plate 38.

FIG. 7F illustrates an exploded view of the splayer base assembly 78 ofone embodiment which includes the splayer base 78, a printed circuitassembly 94, a set of magnets 96, and a back panel 98. During assemblyof a splayer in accordance with some embodiments, the control cables ofthe catheter instrument are pre-tensioned by hand when the pulleys 80are installed. Data related to individual catheter and splayercharacteristics, including, but not limited to, full range of motion andcritical parameters captured during the characterization process, arestored into a memory for later retrieval in the printed circuit assemblyor PCA 94 which can act as a catheter identification (ID) programmableread-only memory (PROM). In alternative embodiments, other typesnon-volatile of memories such as flash memory or electricallyprogrammable read-only memory (EPROM) can be used to store data. The PCAof this embodiment includes a pair of pogo pins 76 to detect contactwith an RCM interface plate. The pogo pins 76 are positioned to makecontact with the PCA 94 upon which the PROM is mounted as the splayer isplaced onto the RCM mounting plate 38. Also located on the underside ofthis splayer base assembly 78 are a pair of magnets 96. In oneembodiment, the magnets 96 are made of a neodymium material. As will belater described, the magnets are configured to be detected by readswitches on the RCM interface to indicate splayer presence when asplayer is mounted on the RCM. The back panel 98 covers portions of thesplayer base assembly 78, which is also shown in FIG. 7F. This backpanel 98 includes openings for the pogo pins 76 to pass through.

Referring back to FIGS. 6A-6B, when a catheter is prepared for use withan instrument, its splayer is mounted onto its appropriate interfaceplate. In this case, the sheath splayer 62 is placed onto the sheathinterface plate 38 and the guide splayer 61 is place onto the guideinterface plate 37. In the illustrated example, each mounting plates 37,38 has four openings 37 a, 38 a that are designed to receive thecorresponding drive shafts 90 attached to and extending from the pulleyassemblies 80 of the splayers 61, 62. In the example illustrated in FIG.6B, two shafts 90 of the pulley assembly 80 are insertable within theright apertures or two openings 38 a of the sheath interface plate 38 asthe splayer 62 is mounted onto the RCM. Similarly, four shafts 90 of theguide splayer pulley assembly 80 are insertable within the fourapertures or openings 37 a of the guide interface plate 37.

The RCM mounting plate in accordance with some embodiments includes aflex circuit with contacts and four read switches (not shown) fordetecting the presence of a splayer and to indicate that a splayer hasbeen mounted onto the interface plate. In some embodiments, the switchesare also used to read the data from the memory. In alternativeembodiments, various types of contacts and switches can be implementedto detect presence and/or access the PCA 94. For this implementation,the switches are triggered by the magnets 96 of the splayer.

A user sets up the catheter by fastened it to the RCM initially. Whenthe bottom surface of the splayer is within 180 thousandths of an inchfrom the interface plate, a magnetic field engages with the contactswitches. The splayer 62/61 is mounted to an RCM, and the latches 73,74are inserted through openings 38 b,37 b on the mounting plate to latchonto the interface plate 38,37, thus securely coupling the splayer 62/61to the RCM. Once the splayer is engaged with the RCM, characterizationparameters can be read from the PCA 94 by the RCM, allowing the RCM toset the splayer in its nominal position. In one embodiment, the dataread from the PCA may include catheter length information, relativelength information for zeroing up a sheath catheter and a guidecatheter, and roll correction information. For example, the computersystem may use the length information to initialize or configure thecatheters for use by adjusting the guide catheter with respect to theguide catheter to ensure the catheters are zeroed up or that the guidecatheter is located in a predefined position relative to the sheathcatheter on the RCM. Similarly, the computer system may take the rollcorrection information, and roll off the catheter if any of the controlwires are a bit offset or skewed, so that the catheter is oriented inthe proper predefined direction (i.e., the ‘up’ direction on thecatheter is really up). The data of one embodiment is gathered throughbench testing during the manufacturing process and programmed into thePROM. In alternative embodiments, the data may have originated from adifferent part of the process. In one implementation, the PROM may alsoinclude a unique identifier or a code to prevent the catheter from beingreused. The system of one embodiment is designed to recognize whether acatheter is brand new or whether it has already been used, and iscapable of rejecting a previously used catheter. For this embodiment,the catheter is pre-tensioned through load sensing so that slack isremoved from the control wires. The catheters are then prepared to bedriven.

The sheath interface mounting plate 38 as illustrated in FIGS. 6A and 6Bis similar to the guide interface mounting plate 37, and thus, similardetails are not repeated. One difference between the plates 37, 38 maybe the shape of the plates. For example, the guide interface plate 37includes a narrow, elongated segment, which may be used with, forexample, a dither mechanism. Both plates 37, 38 include a plurality ofopenings 37 a, 38 a to receive drive shafts 90 and latches 73,74 fromsplayers 61, 62, respectively.

Referring back to FIG. 5C the instrument driver 16 is illustrated withmounting plates 37,38 fixably coupled to a guide carriage 50, and asheath drive block 40, respectively. FIG. 8A illustrates the guidecarriage 50 removed from the instrument driver 16 coupled to cabling 51and associated guide motors 53. The guide carriage 50 includes afunicular assembly 56 which is illustrated in FIG. 8B. The funicularassembly 56 includes four sleeve receptacles 56 b. As previouslydescribed, the drive shafts 90 of the splayer 61 (such as that shown inFIG. 5B) first insert through the openings 37 a in the mounting plate37. They then engage with the sleeve receptacles 56 b. FIGS. 9A-9Billustrate the shafts 90 of the splayer pulley assembly 61 engaging withthe sleeve receptacles (56 b) in further detail. Referring back to FIG.7C, the drive shaft 90 has a flat edge 90 a on one side of itscylindrical surface such that when the drive shaft 90 is viewed alongits longitudinal axis, the shaft has the shape of a letter “D”. Itshould be understood that the drive shaft 90 may include othercross-sectional shapes. The shaft 90 has an opening through which across pin 90 b may be located. The drive shaft 90 may be keyed such thatthe shaft is designed to fit or be received within the receiving sleeve56 b having a certain shape. The sleeve 56 b in the illustrated exampleincludes a pair of V-shaped or wing shaped notches 56 c to receive andhold the pin 90 b of a shaft 90 as the shaft 90 is inserted into thesleeve 56 b. In the illustrated example, the sleeve 56 b does not employcapture pins, although such pins may be utilized.

Referring back to FIG. 8A, a set of cables 51 wound around a set ofpulleys 52, are coupled on one end to a set of guide motors 53 and theother end to the sleeve receptacles 56 b. The drive motors 53 areactuated to rotationally drive the sleeves 56 b. A catheter assembly 30with its splayer 61 mounted onto the instrument drive 16 would have itspulley assemblies 80 positioned inside a plurality of correspondingsleeves 56 b. As the sleeves 56 b are rotated, the pins 90 b of theshafts 90 are seated in the V-shaped notches 56 c and are engaged by therotating sleeves 56 b, thus causing the shafts 90 and associated pulleyassemblies 80 to also rotate. The pulley assemblies 80 in turn cause thecontrol elements (e.g., wires) coupled thereto to manipulate the distaltip of the catheter instrument 30 member in response thereto. To removea splayer from the instrument driver in this implementation, less forceis needed as the V-shaped notches 56 c allow for quick and easydisengagement of the shafts 90 from the sleeves 56 b.

FIGS. 10A and 10B illustrate perspective views of the sheath block 40and motor driven interfaces 42 which are coupled to sheath articulationmotors 43. The sheath articulation motors 43 are coupled the motordriven interfaces 42 which includes a set of belts, shafts, and gearswhich drive receptacle sleeves 56 b (which are similar in constructionand functionality to the receptacle sleeves previously described for theguide funicular assembly). When the sheath splayer drive shafts 90 arecoupled to the receptacle sleeves 56 b, the sheath articulation motors43 drive the receptacle sleeves 56 b causing the sheath instrument 30 tobend.

During use, the catheter instrument 18 is inserted within a centrallumen of the sheath instrument 30 such that the instruments 18, 30 arearranged in a coaxial manner as previously described. Although theinstruments 18, 30 are arranged coaxially, movement of each instrument18, 30 can be controlled and manipulated independently. For thispurpose, motors within the instrument driver 16 are controlled such thatthe drive and sheath carriages coupled to the mounting plates 37, 38 aredriven forwards and backwards independently on linear bearings each withleadscrew actuation. FIG. 10 illustrates the sheath drive block 40removed from the instrument driver coupled to two independently-actuatedlead screw 45, 46 mechanisms driven by insert motors 47. Note only theguide insert motor 47 is shown. The sheath insert motor is not shown inFIG. 10. In the illustrated embodiment, the sheath insertion motor iscoupled to a drive or output shaft (not shown) that is designed to movethe sheath articulation assembly forwards and backwards, thus sliding amounted sheath catheter instrument 18 forwards and backwards. The insertmotion of the guide carriage can be actuated with a similar motorizedleadscrew configuration.

Referring back to FIGS. 1, 2 and 6A, in order to accurately steer arobotic sheath 62 a or guide catheter 61 a from an operator work station2, a control structure should be implemented which allows a user to sendcommands through input devices such as the pendant 8 or MID 12 that willresult in desired motion of the sheath 62 a and guide 61 a. FIGS.11A-11H and 12-16 illustrate examples of a control structure, which aredescribed in further detail in the applications previously incorporatedby reference.

The kinematic relationships for many catheter instrument embodiments maybe modeled by applying conventional mechanics relationships. In summary,a control-element-steered catheter instrument is controlled through aset of actuated inputs. In a four-control-element catheter instrument,for example, there are two degrees of motion actuation, pitch and yaw,which both have + and −directions. Other motorized tension relationshipsmay drive other instruments, active tensioning, or insertion or roll ofthe catheter instrument. The relationship between actuated inputs andthe catheter's end point position as a function of the actuated inputsis referred to as the “kinematics” of the catheter.

Referring to FIGS. 11A-H, the basic kinematics of a catheter 120 withfour control elements 122 a, 122 b, 122 c, 122 d is reviewed. Thecatheter 120 may be component 61 a or component 62 a in someembodiments. Referring to FIGS. 11A-B, as tension is placed only uponthe bottom control element 122 c, the catheter bends downward, as shownin FIG. 11A. Similarly, pulling the left control element 122 d in FIGS.11C-D bends the catheter left, pulling the right control element 122 bin FIGS. 11E-F bends the catheter right, and pulling the top controlelement 122 a in FIGS. 11G-H bends the catheter up. As will be apparentto those skilled in the art, well-known combinations of applied tensionabout the various control elements results in a variety of bendingconfigurations at the tip of the catheter member 120. One of thechallenges in accurately controlling a catheter or similar elongatemember with tension control elements is the retention of tension incontrol elements, which may not be the subject of the majority of thetension loading applied in a particular desired bending configuration.If a system or instrument is controlled with various levels of tension,then losing tension, or having a control element in a slackconfiguration, can result in an unfavorable control scenario. Aspreviously described, each of these control elements or pull wires canbe wound around a pulley which is motor actuated within the instrumentdriver. Maintaining adequate tension with these pulleys can be importantfor accurate catheter control.

FIG. 12 illustrates one example of a control flow for basic cathetercontrol. The operator enters a command to designate a desired tipposition for the device via some input mechanism (a master input device,computer software, or other user interface, etc.). Next, one or moreinverse kinematic algorithms compute a desired catheter configuration inorder to achieve the commanded tip position. The inverse kinematicalgorithm can be varied depending on the construction of the shapeabledevice. The desired catheter configuration is then fed to one or morecatheter mechanics algorithm to compute the positioning elementdisplacements necessary to achieve the desired catheter configuration.These positioning element commands are then provided to the robotscontrol algorithms (or in some cases actuators in the robot thatinterface with positioning elements in the shapeable element).

Based upon the applied positioning element displacements, the actual(physical) catheter mechanics including any constraints and obstructionsacting on the catheter determine the real configuration or shape thatthe shapeable device achieves. This is illustrated on the right(slave/actual) side of FIG. 12. This real catheter configuration/shapedetermines the real catheter tip position. These kinematic relationshipsof the physical device are represented in the figure with a forwardkinematics block 124. Assuming that the operator is observing thecatheter tip through some sort of visualization (fluoro, endoscopy,etc), the operator can then use this visual feedback to make correctionsto the commanded tip position.

Referring to FIG. 13, the “forward kinematics” expresses the catheter'send-point position as a function of the actuated inputs while the“inverse kinematics” expresses the actuated inputs as a function of thedesired end-point position. In certain embodiments, accuratemathematical models of the forward and inverse kinematics are useful forthe control of a robotically controlled catheter system. For clarity,the kinematics equations are further refined to separate out commonelements, as shown in FIG. 13. The basic kinematics describes therelationship between the task coordinates and the joint coordinates. Insuch case, the task coordinates refer to the position of the catheterend-point while the joint coordinates refer to the bending (pitch andyaw, for example) and length of the active catheter. The actuatorkinematics describes the relationship between the actuation coordinatesand the joint coordinates. The task, joint, and bending actuationcoordinates for the robotic catheter are illustrated in FIG. 14. Bydescribing the kinematics in this way we can separate out the kinematicsassociated with the catheter structure, namely the basic kinematics,from those associated with the actuation methodology.

An inverse kinematic model translates intended device motion into thecommands that will adjust the actuator and/or control element toposition the shapeable instrument as desired. Referring back to FIG. 12,the shapeable instrument kinematics are the mathematical relationshipsbetween the task space description of the instrument (e.g., tipposition) and the configuration space description of the instrument(e.g., shape). Specifically, the inverse kinematics (task toconfiguration space) are used as part of the chain that translatesdesired tip positions into actuator commands (leading to displacementsof the control elements) that move tip position of the actual device forreaching a desired tip position.

These inverse kinematic algorithms are derived based upon certainassumptions about how the shapeable instrument moves. Examples of theseassumptions may include, but are not limited to: 1) Each cathetersegment bends in a constant curvature arc; 2) Each catheter segmentbends within a single plane; 3) Some catheter segments have fixed(constant) lengths; 4) Some catheter segments have variable(controllable) lengths.

In one variation, the development of the catheter's kinematics model isderived using a few assumptions. In one example, the included areassumptions that the catheter structure is approximated as a simple beamin bending from a mechanics perspective, and that control elements, suchas thin tension wires, remain at a fixed distance from the neutral axisand thus impart a uniform moment along the length of the catheter.

In addition to the above assumptions, the geometry and variables shownin FIGS. 14 and 15 are used in the derivation of the forward and inversekinematics. The basic forward kinematics, relating the catheter taskcoordinates (X_(c), Y_(c), Z_(c)) to the joint coordinates (Φ_(yaw),Φ_(pitch), L), is given as follows:

X_(c) = ωcos (θ)Y_(c) = Rsin (α)Z_(c) = ωsin (θ) Wherew = R(1 − cos (α)) $\begin{matrix}{\alpha = \lbrack {( \phi_{pitch} )^{2} + ( \phi_{yaw} )^{2}} \rbrack^{1/2}} & ( {{total}\mspace{14mu}{bending}} ) \\{R = \frac{L}{a}} & ( {{bend}\mspace{14mu}{radius}} ) \\{\theta = {{atan}2( {\phi_{pitch}\ ,\phi_{yaw}} )}} & ( {{roll}\mspace{14mu}{angle}} )\end{matrix}$

The actuator forward kinematics, relating the joint coordinates(Φ_(yaw), Φ_(pitch), L) to the actuator coordinates (ΔL_(x),ΔL_(z),L) isgiven as follows:

${ {\Phi_{pitch} = {2\Delta L_{2}}} )/D_{c}}{\phi_{yaw} = \frac{2\Delta L_{x}}{D_{c}}}$

As illustrated in FIG. 13, the catheter's end-point position can bepredicted given the joint or actuation coordinates by using the forwardkinematics equations described above.

Calculation of the catheter's actuated inputs as a function of end-pointposition, referred to as the inverse kinematics, can be performednumerically, using a nonlinear equation solver such as Newton-Raphson.In another approach, shown in the illustrative embodiment, is to developa closed-form solution which can be used to calculate the requiredactuated inputs directly from the desired end-point positions.

As with the forward kinematics, we separate the inverse kinematics intothe basic inverse kinematics, which relates joint coordinates to thetask coordinates, and the actuation inverse kinematics, which relatesthe actuation coordinates to the joint coordinates. The basic inversekinematics, relating the joint coordinates (Φ_(yaw), Φ_(pitch), L), tothe catheter task coordinates (Xc, Yc, Zc) is given as follows:

ϕ_(pitch) = αsin (θ)ϕ_(yaw) = acos (θ)$L =  {R\alpha}arrow {where}arrow\mspace{14mu} arrow\begin{matrix}\overset{{{{{{{{{{{{{......}...}...}...}...}...}...}...}...}...}...}...}.}{\theta = {{atan}\; 2( {Z_{c},X_{c}} )}} & \overset{{{{{{{{{{{{{......}...}...}...}...}...}...}...}...}...}...}...}..}{\beta = {{atan}\; 2( {Y_{c},W_{c}} )}} \\{R = \frac{l\sin\beta}{\sin 2\beta}} &  arrow{W_{c}( {X_{c}^{2} + Z_{c}^{2}} )}^{1/2}  \\{\alpha = {\pi - {2\;\beta}}} & \underset{{{{{{{{{{{{{......}...}...}...}...}...}...}...}...}...}...}...}...}{l = ( {W_{c}^{2} + Y_{c}^{2}} )^{1/2}}\end{matrix}   $

The actuator inverse kinematics, relating the actuator coordinates(ΔL_(x),ΔL_(z),L) to the joint coordinates (Φ_(yaw), Φ_(pitch), L) isgiven as follows:

${{\Delta L_{x}} = \frac{D_{c}\phi_{yaw}}{2}}{{\Delta L_{z}} = \frac{D_{c}\phi_{pitch}}{2}}$

In one embodiment, the catheter (or other shapeable instrument) iscontrolled in an open-loop manner as shown in FIG. 16. In this type ofopen loop control model, the shape configuration command comes in to thebeam mechanics, is translated to beam moments and forces, then istranslated to tendon tensions given the actuator geometry, and finallyinto tendon displacement given the entire deformed geometry. However,there are numerous reasons why the assumed motion of the catheter maynot match the actual motion of the catheter. One important factor is thepresence of unanticipated or unmodeled constraints imposed by thepatient's anatomy.

Accordingly, a control system that directs catheters or shapeableinstruments can command joint configurations that can achieve a desiredtip position. However, the presence of modeling inaccuracies andenvironment interaction causes a differential between the actualposition from that intended. A simple tip position can quantify thiserror, but addressing the source of the error requires the additionalinformation regarding the shapeable instrument. Data defining the actualor real shape of the instrument can provide much of this information.

The term “localization” is used in the art in reference to systems fordetermining and/or monitoring the position of objects, such as medicalinstruments, in a reference coordinate system. In one embodiment, theinstrument localization software is a proprietary module packaged withan off-the-shelf or custom instrument position tracking system, whichmay be capable of providing not only real-time or near real-timepositional information, such as X-Y-Z coordinates in a Cartesiancoordinate system, but also orientation information relative to a givencoordinate axis or system. For example, such systems can employ anelectromagnetic based system (e.g., using electromagnetic coils inside adevice or catheter body). Other systems utilize potential difference orvoltage, as measured between a conductive sensor located on thepertinent instrument and conductive portions of sets of patches placedagainst the skin, to determine position and/or orientation. In anothersimilar embodiment, one or more conductive rings may be electronicallyconnected to a potential-difference-based localization/orientationsystem, along with multiple sets, preferably three sets, of conductiveskin patches, to provide localization and/or orientation data.Additionally, “Fiberoptic Bragg grating” (“FBG”) sensors may be used tonot only determine position and orientation data but also shape dataalong the entire length of a catheter or shapeable instrument.

In other embodiments not comprising a localization system to determinethe position of various components, kinematic and/or geometricrelationships between various components of the system may be utilizedto predict the position of one component relative to the position ofanother. Some embodiments may utilize both localization data andkinematic and/or geometric relationships to determine the positions ofvarious components. The use of localization and shape technology isdisclosed in detail in U.S. patent application Ser. No. 11/690,116, nowabandoned, Ser. No. 11/176,598, now abandoned, Ser. No. 12/012,795, nowabandoned, Ser. No. 12/106,254, issued as U.S. Pat. No. 8,050,523 onNov. 1, 2011, Ser. No. 12/507,727, now abandoned, Ser. No. 12/822,876,issued as U.S. Pat. No. 8,460,236 on Jun. 11, 2013, Ser. No. 12/823,012,now abandoned, and Ser. No. 12/823,032, issued as U.S. Pat. No.8,672,837 on Mar. 18, 2014, the entirety of all of which is incorporatedby reference herein for all purposes.

To accurately coordinate and control actuations of various motors withinan instrument driver from a remote operator control station such as thatdepicted in FIG. 1, an advanced computerized control and visualizationsystem is preferred. The control system embodiments that follow aredescribed in reference to a particular control systems interface, namelythe SimuLink™ and XPC™ control interfaces available from The MathworksInc., and PC-based computerized hardware configurations. However, one ofordinary skilled in the art having the benefit of this disclosure wouldappreciate that many other control system configurations may beutilized, which may include various pieces of specialized hardware, inplace of more flexible software controls running on one or more computersystems.

Referring to FIG. 17, an overview of an embodiment of a controls systemflow is depicted. A master computer 400 running master input devicesoftware, visualization software, instrument localization software, andsoftware to interface with operator control station buttons and/orswitches is depicted. In one embodiment, the master input devicesoftware is a proprietary module packaged with an off-the-shelf masterinput device system, such as the Phantom™ from Sensible DevicesCorporation, which is configured to communicate with the Phantom™hardware at a relatively high frequency as prescribed by themanufacturer. Other suitable master input devices, such as the masterinput device 12 depicted in FIG. 2 are available from suppliers such asForce Dimension of Lausanne, Switzerland. The master input device 12 mayalso have haptics capability to facilitate feedback to the operator, andthe software modules pertinent to such functionality may also beoperated on the master computer 126.

Referring to FIG. 17, in one embodiment, visualization software runs onthe master computer 126 to facilitate real-time driving and navigationof one or more steerable instruments. In one embodiment, visualizationsoftware provides an operator at an operator control station, such asthat depicted in FIG. 2, with a digitized “dashboard” or “windshield”display to enhance instinctive drivability of the pertinentinstrumentation within the pertinent tissue structures. Referring toFIG. 18, a simple illustration is useful to explain one embodiment of apreferred relationship between visualization and navigation with amaster input device 12. In the depicted embodiment, two display views142, 144 are shown. One preferably represents a primary 142 navigationview, and one may represent a secondary 144 navigation view. Tofacilitate instinctive operation of the system, it is preferable to havethe master input device coordinate system at least approximatelysynchronized with the coordinate system of at least one of the twoviews. Further, it is preferable to provide the operator with one ormore secondary views which may be helpful in navigating throughchallenging tissue structure pathways and geometries.

Referring still to FIG. 18, if an operator is attempting to navigate asteerable catheter in order to, for example, contact a particular tissuelocation with the catheter's distal tip, a useful primary navigationview 142 may comprise a three dimensional digital model of the pertinenttissue structures 146 through which the operator is navigating thecatheter with the master input device 12, along with a representation ofthe catheter distal tip location 148 as viewed along the longitudinalaxis of the catheter near the distal tip. This embodiment illustrates arepresentation of a targeted tissue structure location 150, which may bedesired in addition to the tissue digital model 146 information. Auseful secondary view 144, displayed upon a different monitor, in adifferent window upon the same monitor, or within the same userinterface window, for example, comprises an orthogonal view depictingthe catheter tip representation 148, and also perhaps a catheter bodyrepresentation 152, to facilitate the operator's driving of the cathetertip toward the desired targeted tissue location 150.

In one embodiment, subsequent to development and display of a digitalmodel of pertinent tissue structures, an operator may select one primaryand at least one secondary view to facilitate navigation of theinstrumentation. By selecting which view is a primary view, the user canautomatically toggle a master input device 12 coordinate system tosynchronize with the selected primary view. In an embodiment with theleftmost depicted view 142 selected as the primary view, to navigatetoward the targeted tissue site 150, the operator should manipulate themaster input device 12 forward, to the right, and down. The right viewwill provide valued navigation information, but will not be asinstinctive from a “driving” perspective.

To illustrate: if the operator wishes to insert the catheter tip towardthe targeted tissue site 150 watching only the rightmost view 144without the master input device 12 coordinate system synchronized withsuch view, the operator would have to remember that pushing straightahead on the master input device will make the distal tip representation148 move to the right on the rightmost display 144. Should the operatordecide to toggle the system to use the rightmost view 144 as the primarynavigation view, the coordinate system of the master input device 12 isthen synchronized with that of the rightmost view 144, enabling theoperator to move the catheter tip 148 closer to the desired targetedtissue location 150 by manipulating the master input device 12 down andto the right. The synchronization of coordinate systems may be conductedusing fairly conventional mathematic relationships which are describedin detail in the aforementioned applications incorporated by reference.

Referring back to embodiment of FIG. 17, the master computer 126 alsocomprises software and hardware interfaces to operator control stationbuttons, switches, and other input devices which may be utilized, forexample, to “freeze” the system by functionally disengaging the masterinput device as a controls input, or provide toggling between variousscaling ratios desired by the operator for manipulated inputs at themaster input device 12. The master computer 126 has two separatefunctional connections with the control and instrument driver computer128: one connection 132 for passing controls and visualization relatedcommands, such as desired XYZ (in the catheter coordinate system)commands, and one connection 134 for passing safety signal commands.Similarly, the control and instrument driver computer 128 has twoseparate functional connections with the instrument and instrumentdriver hardware 130: one connection 136 for passing control andvisualization related commands such as required-torque-related voltagesto the amplifiers to drive the motors and encoders, and one connection138 for passing safety signal commands.

Also shown in the signal flow overview of FIG. 17 is a pathway 140between the physical instrument and instrument driver hardware 130 backto the master computer 126 to depict a closed loop system embodimentwherein instrument localization technology, previously described, isutilized to determine the actual position of the instrument to minimizenavigation and control error, as described in further detail below.

FIGS. 19A-K depict various aspects of one embodiment of a SimuLink™software control schema for an embodiment of the physical system, withparticular attention to an embodiment of a “master following mode.” Inthis embodiment, an instrument is driven by following instructions froma master input device, and a motor servo loop embodiment, whichcomprises key operational functionality for executing upon commandsdelivered from the master following mode to actuate the instrument.

FIG. 19 depicts a high-level view of an embodiment wherein any one ofthree modes may be toggled to operate the primary servo loop 154. Inidle mode 156, the default mode when the system is started up, all ofthe motors are commanded via the motor servo loop 154 to servo abouttheir current positions, their positions being monitored with digitalencoders associated with the motors. In other words, idle mode 156deactivates the motors, while the remaining system stays active. Thus,when the operator leaves idle mode, the system knows the position of therelative components. In auto home mode 158, cable loops within anassociated instrument driver, such as that depicted in FIG. 5A-5C, arecentered within their cable loop range to ensure substantiallyequivalent range of motion of an associated instrument in bothdirections for a various degree of freedom, such as + and − directionsof pitch or yaw, when loaded upon the instrument driver. This is a setupmode for preparing an instrument driver before an instrument is engaged.

In master following mode 160, the control system receives signals fromthe master input device, and in a closed loop embodiment from both amaster input device and a localization system, and forwards drivesignals to the primary servo loop 154 to actuate the instrument inaccordance with the forwarded commands. Aspects of the primary servoloop and motor servo block 162 are depicted in further detail in FIGS.20-23.

Referring to FIG. 24, a more detailed functional diagram of anembodiment of master following mode 160 is depicted. As shown in FIG.24, the inputs to functional block 170 are XYZ position of the masterinput device in the coordinate system of the master input device which,per a setting in the software of the master input device may be alignedto have the same coordinate system as the catheter, and localization XYZposition of the distal tip of the instrument as measured by thelocalization system in the same coordinate system as the master inputdevice and catheter. Referring to FIG. 25 for a more detailed view offunctional block 170 of FIG. 24, a switch 186 is provided to allowswitching between master inputs for desired catheter position, to aninput interface 188 through which an operator may command that theinstrument go to a particular XYZ location in space. Various controlsfeatures may also utilize this interface to provide an operator with,for example, a menu of destinations to which the system shouldautomatically drive an instrument, etc. Also depicted in FIG. 25 is amaster scaling functional block 184 which is utilized to scale theinputs coming from the master input device with a ratio selectable bythe operator. The command switch 186 functionality includes a low passfilter to weight commands switching between the master input device andthe input interface 188, to ensure a smooth transition between thesemodes.

Referring back to FIG. 24, desired position data in XYZ terms is passedto the inverse kinematics block 174 for conversion to pitch, yaw, andextension (or “insertion”) terms in accordance with the predictedmechanics of materials relationships inherent in the mechanical designof the instrument. The pitch, yaw, and extension commands are passedfrom the inverse kinematics 174 to a position control block 172 alongwith measured localization data. FIG. 29 provides a more detailed viewof the position control block 172. After measured XYZ position datacomes in from the localization system, it goes through a inversekinematics block 189 to calculate the pitch, yaw, and extension theinstrument needs to have in order to travel to where it needs to be.Comparing 191 these values with filtered desired pitch, yaw, andextension data from the master input device, integral compensation isthen conducted with limits on pitch and yaw to integrate away the error.In this embodiment, the extension variable does not have the same limits193, as do pitch and yaw 195. As will be apparent to those skilled inthe art, having an integrator in a negative feedback loop forces theerror to zero. Returning to FIG. 24, desired pitch, yaw, and extensioncommands are next passed through a catheter workspace limitation 176,which may be a function of the experimentally determined physical limitsof the instrument beyond which componentry may fail, deform undesirably,or perform unpredictably or undesirably. This workspace limitationdefines a volume similar to a cardioid-shaped volume about the distalend of the instrument. Desired pitch, yaw, and extension commands,limited by the workspace limitation block, are then passed to a catheterroll correction block 178.

This functional block is depicted in further detail in FIG. 26, andcomprises a rotation matrix for transforming the pitch, yaw, andextension commands about the longitudinal, or “roll”, axis of theinstrument—to calibrate the control system for rotational deflection atthe distal tip of the catheter that may change the control elementsteering dynamics. For example, if a catheter has no rotationaldeflection, pulling on a control element located directly up at twelveo'clock should urge the distal tip of the instrument upward. If,however, the distal tip of the catheter has been rotationally deflectedby, say, ninety degrees clockwise, to get an upward response from thecatheter, it may be necessary to tension the control element that wasoriginally positioned at a nine o'clock position. The catheter rollcorrection schema depicted in FIG. 26 provides a means for using arotation matrix to make such a transformation, subject to a rollcorrection angle, such as the ninety degrees in the above example, whichis input, passed through a low pass filter, turned to radians, and putthrough rotation matrix calculations.

In one embodiment, the roll correction angle is determined throughexperimental experience with a particular instrument and path ofnavigation. In another embodiment, the roll correction angle may bedetermined experimentally in-situ using the accurate orientation dataavailable from the preferred localization systems. In other words, withsuch an embodiment, a command to, for example, bend straight up can beexecuted, and a localization system can be utilized to determine atwhich angle the defection actually went—to simply determine the in-situroll correction angle.

Referring briefly back to FIG. 24, roll corrected pitch and yawcommands, as well as unaffected extension commands, are output from theroll correction block 178 and may optionally be passed to a conventionalvelocity limitation block 180. Referring to FIG. 27, pitch and yawcommands are converted from radians to degrees, and automaticallycontrolled roll may enter the controls picture to complete the currentdesired position 190 from the last servo cycle. Velocity is calculatedby comparing the desired position from the previous servo cycle, ascalculated with a conventional memory block (192) calculation, with thatof the incoming commanded cycle. A conventional saturation block 187keeps the calculated velocity within specified values, and thevelocity-limited command 194 is converted back to radians and passed toa tension control block 182.

Tension within control elements may be managed depending upon theparticular instrument embodiment, as described above in reference to thevarious instrument embodiments and tension control mechanisms. As anexample, FIG. 28 depicts a pre-tensioning block 196 with which a givencontrol element tension is ramped to a present value. An adjustment isthen added to the original pre-tensioning based upon a preferablyexperimentally-tuned matrix pertinent to variables, such as the failurelimits of the instrument construct and the incoming velocity-limitedpitch, yaw, extension, and roll commands. This adjusted value is thenadded 198 to the original signal for output, via gear ratio adjustment,to calculate desired motor rotation commands for the various motorsinvolved with the instrument movement. In this embodiment, extension,roll, and sheath instrument actuation 199 have no pre-tensioningalgorithms associated with their control. The output is then completefrom the master following mode functionality, and this output is passedto the primary servo loop 154.

Referring back to FIG. 19, incoming desired motor rotation commands fromeither the master following mode 160, auto home mode 158, or idle mode156 in the depicted embodiment are fed into a motor servo block 162,which is depicted in greater detail in FIGS. 20-23.

Referring to FIG. 20, incoming measured motor rotation data from digitalencoders and incoming desired motor rotation commands are filtered usingconventional quantization noise filtration 164 at frequencies selectedfor each of the incoming data streams to reduce noise while not addingundue delays which may affect the stability of the control system. Asshown in FIGS. 22 and 23, conventional quantization filtration isutilized on the measured motor rotation signals at about 200 hertz inthis embodiment, and on the desired motor rotation command at about 15hertz. The difference 166 between the quantization filtered values formsthe position error which may be passed through a lead filter, thefunctional equivalent of a proportional derivative (“PD”)+low passfilter. In another embodiment, conventional PID, lead/lag, or statespace representation filter may be utilized. The lead filter of thedepicted embodiment is shown in further detail in FIG. 21.

In particular, the lead filter embodiment in FIG. 21 comprises a varietyof constants selected to tune the system to achieve desired performance.The depicted filter addresses the needs of one embodiment of a 4-controlelement guide catheter instrument with independent control of each offour control element interface assemblies for .+−.pitch and .+−.yaw, andseparate roll and extension control. As demonstrated in the depictedembodiment, insertion and roll have different inertia and dynamics asopposed to pitch and yaw controls, and the constants selected to tunethem is different. The filter constants may be theoretically calculatedusing conventional techniques and tuned by experimental techniques, orwholly determined by experimental techniques, such as setting theconstants to give a sixty degree or more phase margin for stability andspeed of response, a conventional phase margin value for medical controlsystems.

In an embodiment where a tuned master following mode is paired with atuned primary servo loop, an instrument and instrument driver, such asthose described above, may be “driven” accurately in three-dimensionswith a remotely located master input device. Other preferred embodimentsincorporate related functionalities, such as haptic feedback to theoperator, active tensioning with a split carriage instrument driver,navigation utilizing direct visualization and/or tissue models acquiredin-situ and tissue contact sensing, and enhanced navigation logic.

I-A. Insertion Force Indicator

Referring to FIGS. 30-31, a further embodiment is directed systems andmethods for indicating catheter 61 a insertion forces. When the guidecatheter 61 a extends from the sheath 62 a and makes contact withtissue, a certain force F is imparted onto the guide catheter 61 a.Depending on how far the distal tip 92 of the guide catheter 61 a isextended from the sheath 62 a, the force F may result in differentinteractions between the guide catheter 61 a and tissue.

In one variation as illustrated in FIG. 30, a length L₁ of the guidecatheter instrument 61 a extends beyond the distal tip 91 of the sheath62 a. As the distal tip 92 of the guide catheter 61 a makes contact withtissue with a force F, an equal and opposite force F is imparted to theguide catheter instrument 61 a (represented by arrow F). Depending uponthe magnitude of the force F, a portion of the guide catheter 61 a,e.g., adjacent to the distal tip 92, may be caused to bend, flex orbuckle under the force F, thereby reducing the force exerted on thetissue.

FIG. 31 illustrates a guide catheter 61 a that extends a shorter lengthL₂ beyond the distal tip 91 of the sheath 62 a. In this example, whenthe distal tip 92 of the guide catheter 61 a makes contact with tissuewith the same force F, the shorter length L₂ reduces or eliminatesflexing since the distal portion of the guide catheter 61 a isreinforced by the distal end of the stiffer sheath 62 a, resulting in alarger force F that is applied to the tissue due to less flexing.

In one system (S), motors of the instrument driver 16 are controlled torobotically control and manipulate catheter instruments 18. The amountof current supplied to the motor is proportionally related to the amountof torque generated by the motors and catheter 18 insertion force isproportional to the motor torque. Thus, the motor current isproportional to the insertion force. If the motors are driven by thesame amount of current regardless of how far the guide catheter 61 aextends out from the sheath 62 a, the force imparted on the tissue atthe contact point may differ based on length L. For example, if a highmotor current causes a high insertion force for a guide catheter 61 aextending length L₁, the catheter 61 a may dissipate a portion of thatforce due to flexing or bending. However, when the guide catheter 61 aextends a much smaller length L₂, it may not yield, and the insertionforce is not attenuated. In one embodiment, a kinematic model of theinstrument configuration may be utilized, in concert with sensed motortorques at driveshafts within the instrument driver, to calculate, or“back out”, the loads and vectors thereof that are theoretically appliedto the distal end of the instrument, or other portion of the instrumentin contact with an external load-applying structure.

In one embodiment, a system (S) may be configured to generate a visualor audible warning message to a user, control element or processorindicating that corrective action is required and/or to indicate apossibility of high insertion forces exerted to tissue at the distal tip92. In one embodiment, a warning message is displayed when length L isless than a minimum length L_(min) and/or the motor current I is greaterthan I_(max). For example, the minimum length L_(min) may be about 30 mmor less, and the maximum motor current I_(max) may be about 250 mA orhigher current levels. In cases in which the length or motor currentexceeds these pre-determined values, the operator may adjust the motorcurrent accordingly or proceed carefully to avoid causing injury. Thistype of force indication message may be useful for instrument driver 16that do not have force sensing capabilities.

I-B. Reachability/Viewability

Another alternative embodiment is directed to methods and systems forassessing reachability and viewability at a particular location. Moreparticularly, embodiments advantageously assess locations within thebody that can be reached by a catheter instrument 18 of the system (S),as well as assessing the viewability or field of view at a particularlocation that can be reached by the catheter instrument 18. This abilityis particularly significant since the field of view at a particularlocation may not be desirable even if it is reachable. Thus, embodimentsadvantageously assess field of view at reachable locations in order toprovide more meaningful surgical planning and results.

For example, in the context of cardiac surgery utilizing an intracardiac(ICE) catheter. During the planning stage, an operator can determineoffline before a procedure where a catheter should be driven to providefor a desired field of view that allows a region of interest to bescanned. Alternatively, a previously acquired CT model may be registeredand fused with real time ultrasound data during a surgical procedure.During use, embodiments allow the ICE catheter to be driven to aposition within the heart with a desired or optimum field of view forscanning of, e.g., the left atrium, or another internal tissue orsegment thereof that is of interest.

Referring to FIG. 32, in one embodiment, a robotic medical systemincludes an outer sheath 62 a with a working lumen, and an inner guidecatheter 61 a extending through the sheath lumen, with a distal endportion of the guide catheter 61 a extending out a distal end opening ofthe sheath 62 a in an anatomic workspace 116 in a body. An intracardiac(ICE) ultrasound imaging catheter 112 is positioned in a working lumenof the guide catheter 61 a, with a distal end portion of the ICEcatheter 112 extending out a distal end opening of the guide catheter 61a. The ICE catheter 112 may be extended out of, and retracted into,respectively, the distal end opening in the guide catheter 61 a, asindicated by arrow 115A, and may be rotated about its longitudinal axis,as indicated by arrow 115B, such that a transducer array 113 on the ICEcatheter 112 is positionable within the anatomic workspace 116 tocapture ultrasound images within a field of view 114 of the array 113.The depicted ICE catheter 112 comprises a substantially linear array 113defining a field of view 114 having a substantially trapezoidal shape;ICE catheters with such configurations are available from suppliers suchas the Ultrasound division of Siemens AG under the tradename AcuNav™. Inother embodiments, substantially circular/disc shaped fields of view maybe created utilizing an ultrasound transducer configuration which may berotated along with a portion of the ICE catheter with a drive shaft, asin the ICE catheters available from Boston Scientific, or utilizingmultiple ultrasound transducers placed circumferentially around acatheter body, as in the ultrasound imaging catheters available fromVolcano Corporation. For illustrative purposes, FIG. 32 depicts a lineararray, AcuNav™ type configuration—but each of the aforementioned otherconfigurations may be similarly employed.

Depending on factors such as the anatomical boundaries and tissuestructures in the anatomical workspace 116, and the relative positionsand prior trajectories of the sheath 62 a, guide catheter 61 a, and ICEcatheter 112 within the workspace 116, the system controller (not shownin FIG. 32) can model the potential relative movement the respectivesheath 62 a, guide 61 a, and ICE catheter 112, and thus the potentialmovement of the field of view 114 of the transducer array 113 within thework space 116. In particular, certain tissue walls and/or structureswithin the anatomic workspace 116 can be readily imaged (or “viewable”)by the ICE transducer 113 without requiring anything more than arelatively simple repositioning of the respective sheath 62 a, guide 61a, and ICE catheter 112, respectively, such as tissue structure 117 inFIG. 21. Other tissue wall locations and/or structures may be viewable,but only by more complicated maneuvering techniques, including iterativemovements of one or more of the sheath 62 a, guide 61 a, and/or ICEcatheter 112, respectively, in order to position the transducer 113 andfield of view 114, such as tissue structure 118 in FIG. 32. Stillfurther tissue wall locations and/or structures may be difficult orimpossible to capture within the field of view 114 of the ICE transducer113 without a major repositioning of the collective instruments (sheath62 a, guide 61 a, ICE catheter 112), if at all.

This “ICE viewability” analysis may be useful for both pre-operativeplanning, and during a procedure, wherein the robotic system controlleris configured to determine a respective reach of the distal end portionof the ICE catheter 112, and thus the potential fields of view 114 thatmay be captured by the transducer array 113 within the anatomicalworkspace 116, based at least in part upon a planned or a presentrelative position of the respective sheath 62 a, guide 61 a, and ICEcatheter 112 instruments. By way of non-limiting examples, thecontroller may determine the viewability of the various anatomic wallsurfaces and/or tissue structures based at least in part on a kinematicmodel of one or both of the sheath and guide catheter instruments 62 aand 61 a. Further, the controller may display the possible field ofviews, viewable tissue walls and/or structures, or both, overlaying animage of the anatomic workspace on a display associated with the roboticsystem, wherein the image of the anatomic workspace is obtained from amodel of the workspace, from an imaging system, or both.

While various embodiments haven been described herein, such disclosureis provided for purposes explanation and illustration. Further, variousembodiments may be used in combination with other embodiments.Additionally, although certain embodiments are described with referenceto particular dimensions or parameters, it should be understood thatthese dimensions and parameters are provided for purposes ofexplanation, and that other dimensions and parameters may also beutilized.

Embodiments and instruments of robotic systems (S) may be used invarious minimally invasive surgical procedures that involve differenttypes of tissue including heart, bladder and lung tissue, for example.Depending on the procedure, distal portions of various instruments maynot be easily visible to the naked eye. Various imaging modalitiesincluding magnetic resonance (MR), ultrasound, computer tomography (CT),X-ray, fluoroscopy, etc. may be used for this purpose to visualize thesurgical procedure and location of instruments. Further, it may bedesirable to know the precise location of a given catheter instrumentand/or working tool at any given moment to avoid undesirable contacts ormovements. For this purpose, one or more localization techniques thatare presently available may be applied to any of the apparatuses andmethods disclosed above. For example, one or more localization coils maybe built into a flexible catheter instrument. In other implementations,a localization technique using radio-opaque markers may be used withembodiments of the present invention. Similarly, a fiber optic Braggsensing fiber may be built into the sidewall of a catheter instrument tosense position and temperature. Embodiments may also be implemented insystems that include a plurality of sensors, including those for sensingpatient vitals, temperature, pressure, fluid flow, force, etc., may becombined with the various embodiments of flexible catheters and distalorientation platforms disclosed herein.

Embodiments of flexible catheters and other related instruments used ina robotic surgical system may be made of various materials, includingmaterials and associated techniques that are the same as or similar tothose described in U.S. patent application Ser. No. 11/176,598, nowabandoned, the contents of which were previously incorporated byreference. For example, suitable materials may include stainless steel,copper, aluminum, nickel-titanium alloy (Nitinol), Flexinoff (availablefrom Toki of Japan), titanium, platinum, iridium, tungsten,nickel-chromium, silver, gold, and combinations thereof, may be used tomanufacture parts such as control elements, control cables, spineelements, gears, plates, ball units, wires, springs, electrodes,thermocouples, etc. Similarly, non-metallic materials including, but notlimited to, polypropylene, polyurethane (Pebax™), nylon, polyethylene,polycarbonate, Delrin™, polyester, Kevlar™, carbon, ceramic, silicone,Kapton™ polyimide, Teflon™ coating, polytetrafluoroethylene (PTFE),plastic (nonporous or porous), latex, polymer, etc. may be used to makethe various parts of a catheter and other system components.

Further, although embodiments are describe with reference to a catheterin the form of a guide catheter and working instruments, it is alsocontemplated that one or more lumens of catheters may be used to deliverfluids such as saline, water, carbon dioxide, nitrogen, helium, forexample, in a gaseous or liquid state, to the distal tip. Furthermore,it is contemplated that some embodiments may be implemented with a openloop or closed loop cooling system wherein a fluid is passed through oneor more lumens in the sidewall of the catheter instrument to cool thecatheter or a tool at the distal tip.

Further, although various embodiments are described with reference to asheath and/or a guide catheter having four control elements or pullwires, it may be desirable to have a guide instrument with differentnumbers of control elements, e.g., less than four control elements.Further, although certain embodiments are described with reference to aguide catheter in combination with a steerable sheath, other embodimentsmay be implemented in systems that include a guide catheter (or othercatheter) in combination with a pre-bent, unsteerable sheath, or perhapswith no sheath at all. Further, embodiments described above may beutilized with manually or robotically steerable instruments, such asthose described in U.S. patent application Ser. No. 11/481,433, issuedas U.S. Pat. No. 8,052,636 on Nov. 8, 2011, incorporated herein byreference. The instrument driver can be configured and adapted to meetthe needs of different system and instrument configurations, e.g., usingdifferent numbers of motors and gearboxes for driving control elements,or variation in the configuration for actuating a given control elementinterface assembly, and associated variation in the tensioning mechanismand number of control element pulleys associated with the pertinentcontrol element interface assembly (one pulley and one cable per controlelement interface assembly, two pulleys and two cables per controlelement interface assembly, slotted, split carriage, and winged splitcarriage embodiments, various tensioning embodiments, etc.

II. Catheter

FIG. 33A illustrates a cross-sectional view of a section or portion of aflexible and steerable elongate instrument or catheter 300 of aninstrument assembly in accordance with some embodiments. The catheter300 may be coupled to the drivable assembly 182 in some embodiments. Thesteerable elongate instrument 300 may be substantially pliable orflexible such that when it is advanced into a patient, an operator orsurgeon may easily manipulate the instrument 300 to conform, adopt, ormatch the shape or curvatures of the internal pathways (e.g.,gastrointestinal tract, blood vessels, etc.) of the patient. Asillustrated, the flexible and steerable elongate instrument or catheter300 may be comprised of multiple layers of materials and/or multipletube structures. For example, the elongate instrument 300 may include anouter layer or outer tube 302, a main lumen, primary lumen, or centrallumen 318 defined by an inner layer or inner tube 312, and minor,secondary, or peripheral lumens incorporated in the body of the elongateinstrument 300 substantially between the outer layer 302 and the innerlayer 312 where operational tubes 304, flexible tubes 306, push tubes308, and support tubes 310 are disposed or contained. The lumen 318 maybe used to deliver one or more surgical instruments or tools from theproximal portion of the elongate instrument 300 to the distal portion ofthe elongate instrument 300 where they may be positioned and used totreat a target tissue structure inside a patient. The outer layer orouter tube 302 and the inner layer or inner tube 312 may be made of anyflexible, pliable, or suitable polymer material or bio-compatiblepolymer material (e.g., nylon-12, Pebax®, Pellathane, Polycarbonate,etc.) or braided plastic composite structure. In some embodiments, outerlayer or outer tube 302 and the inner layer or inner tube 312 may be onelayer of material or one tube structure instead of separate layers ofmaterial or separate tube structures. Operational tubes 304 may not beactual tubes but may be the minor, secondary, or peripheral lumens orchannels through the body of the outer layer or outer tube 302 or theoperational tubes 304 may be separate operational tube structures thatare disposed inside the minor, secondary, or peripheral lumens orchannels in the body structure of the outer layer or outer tube 302. Theoperational tubes 304 may be made of any suitable polymer material,bio-compatible polymer material or metallic material (e.g., polyimide,stainless steel or spiral cut stainless steel, Nitinol, etc.). Theseparate operational tubes 304 may be melted and/or braided into thewall of the minor, secondary, or peripheral lumens of the outer tube 302or inner tube 312. The operational tubes 304 may provide a substantiallyslidable surface and interface for the flex tubes 306, such that theflex tubes 306 may slide substantially freely about the interior of theoperational tubes 304 in a substantially decoupled configuration. Insome embodiments, a distal end or portion of the flex tubes 306 may befixedly coupled to the elongate instrument. In some variations, aproximal end or portion of the flex tubes may also be fixedly coupled tothe elongate instrument 300 as in a passively controlled configurationof the flex tubes 306.

For example, in a passively controlled configuration, the flex tubes 306may passively slide along the interior of the operational tubes as theelongate instrument or catheter 300 is navigated through the anatomy,articulated or steered. As will be discussed in more detail, theslidable interface between the flex tubes 306 and the operational tubes304 together with buffer loops of the flex tubes in the control unitsubstantially decouple the flex tubes 306 from the elongate instrumentor catheter 300. Because of the decoupled configuration of these twostructures, articulation forces supported by the flex tubes may bedecoupled from at least a portion of the catheter body or structure 300.As a result of decoupling the flex tubes 306 from at least a portion thecatheter body or structure, articulation forces applied to articulate orsteer the distal portion of the elongate instrument or catheter 300 maynot be transmitted through or along the body of the elongate instrumentfrom the distal portion to the proximal portion of the elongateinstrument, for example. Consequently, as described in this example,articulation forces may be prevented or minimized from compressing theproximal portion of the elongate instrument or catheter body; suchcompression if allowed to occur, may affect the stiffness or bendingstiffness of the proximal portion of the catheter. In addition, thisdecoupling of the articulation forces for the elongate member allowsthat changes in the shape or length of the elongate member as it isnavigated through the anatomy may not have any impact or minimal impacton the articulation performance of the distal section of the elongateinstrument. As will be also discussed in more detail, in someembodiments, the flex tubes 306 may also be utilized as support orreinforcing structures to vary or change the stiffness and/or bendradius of at least a portion of the catheter. In particular, the flextubes 306 may be very effective support or reinforcing structures whenthey are compressed and stiffened. In other words, an elongateinstrument 300 or a section of the elongate instrument without any flextubes 306 may be substantially flexible. With the introduction of one ormore flex tubes 306 into the body of the elongate instrument or asection of the elongate instrument, the elongate instrument or thesection of the elongate instrument with the flex tubes 306 may becomeless flexible; even though the flex tubes 306 are flexible in bending,they have axial stiffness. Several axially stiff members spreadthroughout the cross section of a catheter may add significant bendingstiffness to the catheter. When the flex tubes 306 are compressed, suchas using pull wires to apply a compressible force or load to the flextubes, for example, they may become substantially more stiff laterally,such that the stiffened structures may affect or alter the stiffnessand/or bend radius of at least a portion of the catheter where the flextubes 306 are located. Accordingly, the flex tubes 306 may be utilizedto vary or change the stiffness and/or bend radius of a portion orcertain portion of the catheter by changing the positioning or placementof the flex tubes 306 in the elongate instrument 300. For example, theflex tubes 306 may be moved from one portion of the elongate instrumentor catheter to another portion of the catheter. The portion from whichwhere the flex tubes 306 were moved may become substantially moreflexible or pliable without the flex tubes 306. Whereas, the portion towhich where the flex tubes 306 were moved to may become substantiallymore stiff or less flexible or pliable. Consequently, the changes ofstiffness along various portions of the elongate instrument or cathetermay substantially affect the bend radius of at least a portion of theelongate instrument as pull wires are operated to articulate or steerthe elongate instrument.

Referring back to the structural make up of the steerable instrument 300as illustrated in FIG. 33A, the flex tubes 306 may be made from a coilof wire, a stack of rings, or a tube with spirally cut features. As maybe appreciated by one of ordinary skilled in the art, a substantiallystiff tube may become less stiff or more flexible or more pliable as aspiral cut or spirally cut feature is imparted onto a substantiallystiff tube. The tube may be made from a of a high durometer plastic suchas Peek™ or stainless steel or other suitable material. One of thefeatures of the flex tube 306 is that it may provide structural supportto the elongate instrument (e.g., axial and lateral support) as well asbeing substantially flexible (e.g., able to bend in various directionsand orientations). In some embodiments, the flex tubes 306 may beconstructed from one continuous coil of wire, e.g., coil tube. In otherembodiments, each flex tube 306 may include a plurality of coils thatare axially aligned in series. In some other embodiment, the flex tube306 may be constructed from a stack of rings, e.g., ring tube. For aring tube, the rings may be stacked, grouped, or maintained together inany suitable manner. In some of the embodiments, the rings may bestacked, grouped, or maintained together by a substantially flexiblesleeve, sheath, membrane, or covering. The coil of wire or rings may bemade from a polymer material or metallic material. For example, a coilwire or rings may be made from stainless steel, Nitinol, etc. The coilwire may be made from a round stock or a flat stock or a stock havingany cross-section or profile. Similarly, the rings of the ring tube maybe made from a round stock or a flat stock or a stock having anycross-section or profile. In accordance with some embodiments, the flextubes 306 may be generally constructed from a substantially tightlywound coil of wire or a stack of rings.

Still referring to FIG. 33A, the support tubes 310 may be made of anysuitable polymer material, bio-compatible polymer material, or metallicmaterial (e.g., polyimide, stainless steel, Nitinol, etc.). The innerlayer or inner tube 312 may be made of any suitable polymer material orbio-compatible polymer material (e.g., nylon-12, Pebax®, Pellathane,Polycarbonate, etc.). In addition, the elongate instrument 300 mayinclude a control ring 316 that may be secured near a distal portion ofthe elongate instrument 300. In various embodiments, the proximal end orportion of one or more pull wires 314 may be operatively coupled tovarious mechanisms (e.g., gears, pulleys, etc.) of a control unit orsplayer (such as the drivable instrument 182) of the instrumentassembly. The pull wire 314 may be a metallic wire, cable or thread, orit may be a polymeric wire, cable or thread. The pull wire 314 may alsobe made of natural or organic materials or fibers. The pull wire 314 maybe any type of suitable wire, cable or thread capable of supportingvarious kinds of loads without deformation, significant deformation, orbreakage. The distal end or portion of one or more pull wires 314 may beanchored or mounted to the control ring 316, such that operation of thepull wires 314 by the control unit or splayer may apply force or tensionto the control ring 316 which may steer or articulate (e.g., up, down,pitch, yaw, or any direction in-between) certain section or portion(e.g., distal section) of the elongate instrument 300. In otherembodiments, no control ring may be used, instead the distal portion ofthe pull wires may be attached directly to a section or portion of theelongate instrument 300 where it may be steered, articulated, or bent.The wires may be crimped, soldered, welded or interlocked in anysuitable manner to a specific location on a bending section or portionof the elongate instrument 300. The control ring 316 or the attachmentpoint(s) may be located at any location, section, portion, or regionalong the length of the elongate instrument 300. Operation of the pullwires 314 may steer or articulate any of the location, section, portion,or region of the elongate instrument 300, which may in effect provide ordefine various bend radii for the articulated portion of the elongateinstrument 300. In addition, in some embodiments there may be more thanone control ring 316 mounted or installed to the elongate instrument 300or more than one control wire attachment control locations, sections, orportions for controlling, steering, or articulating more than onesection or portion of the elongate instrument 300. In some embodiments,the flexible and steerable elongate instrument 300 having more than onecontrol rings 316 or more than one control sections may be steered,articulated, or deflected into various complex shapes or curvatures(e.g., “S” curved shapes or “J” curved shapes, etc.). For example, thesteerable elongate instrument 300 may be steered, articulated, ordeflected into various complex shapes or curvatures that may conform tovarious complex shapes or curvatures of internal pathways of a patientto reach a target tissue structure of an organ inside the patient.

In some embodiments, one or more portions of the flex tubes 306 may beincorporated or coupled to the wall of the catheter 300 and suchincorporation or coupling may be used for multiple functional purposes.For example, the coupling of the flex tubes 306 to the elongateinstrument 300 may be used to support articulation forces as theelongate instrument or catheter is steered or articulated. Also, in someembodiments, proximal portions of the flex tubes 306 may be slidablerelative to the elongate instrument 300. As one or more of the pullwires 314 are operated by the control unit to steer or articulate theelongate instrument 300, the articulation or steering forces may besubstantially transmitted along the body of the elongate instrument 300from the portion (e.g., distal portion) of the elongate instrument 300where the distal end or portion of the pull wires 314 may be anchored tothe proximal portion of the elongate instrument 300. Since the flextubes 306 are incorporated or coupled to the wall of the elongateinstrument 300 and the flex tubes 306 are substantially configured tosupport axial loading, the articulation or steering loads may bedecoupled from the elongate instrument 300 at the point or locationwhere the flex tubes 306 are incorporated or coupled to the wall of theelongate instrument 300. Hence, the proximal portion of the elongateinstrument may be substantially unaffected by the articulation orsteering of the particular section or portion (e.g., distal section orportion) of the elongate instrument 300. The proximal portion of theelongate instrument may remain substantially flexible and pliable evenwhen a particular portion (e.g., distal portion) of the elongateinstrument is being articulated or steered. The above feature allowstension to be applied to steer the distal section of the elongateinstrument 300 while steering force is isolated from the proximalsection of the elongate instrument 300 (and as a result, a bendingstiffness of the proximal section of the elongate instrument 300 is notsignificantly affected). The above feature also allows tension to beapplied to steer the distal section of the elongate instrument 300without creating unwanted curvature at the proximal section of theelongate instrument 300, and thus, a shape of the proximal section ofthe elongate instrument 300 is unaffected by the steering of the distalsection. As such, an operator or surgeon may easily manipulate theelongate instrument 300 and urge it to conform, adopt, or match thevarious shape or curvatures of the internal pathways of a patient whilethe elongate instrument is being advanced and steered to reach varioustissue structures or target sites inside a patient. In another exampleor application of the elongate instrument 300, the flex tubes 306 may beused as a structural support member to the catheter 300; in particular,when the flex tubes are stiffened by tensioning pull wires that may beattached to the flex tubes 306. In such application, the flex tubes 306may support not only axial forces or loads, but also lateral forces orloads. As such, the flex tubes may increase the lateral as well asbending stiffness of at least a portion or section of the elongateinstrument 300. In addition, the flex tubes 306 may also affect thebending radius of at least a portion or section of the elongateinstrument 300 as the elongate instrument is steered, articulated, ormanipulated.

In some embodiments, each flex tubes 306 may be located closer to a wallof the elongate instrument 300 than an axis (e.g., central axis) of theelongate instrument 300. For example, in some variations, each flextubes 306 may be located close to a wall of the elongate instrument 300.This allows the elongate instrument 300 to have a central working lumenextending therethrough. In some cases, such central working lumen mayhave a cross sectional area that is at least 30% of the cross sectionalarea of the elongate instrument 300. Also, in one or more of theembodiments described herein, each flex tube 306 may have a proximal tipthat is proximal to a proximal tip of the tubular body of the elongateinstrument 300.

FIG. 33B illustrates another cross-sectional view (View 1-1) of asection or portion of a steerable elongate instrument or catheter 300.As illustrated in FIG. 33B, the components of the elongate instrument300 may be contained within or between the outer layer of material orouter tube 302 and the inner layer of material or inner tube 312. Aprimary, main, central, or working lumen 318 may be provided or definedby the inner layer of material or inner tube 312. The main lumen orcentral lumen 318 may be used to pass surgical instruments from theproximal end to the distal end of the elongate instrument 300 forperforming various minimally invasive surgical procedures. Many of thecomponents of the elongate instrument 300, e.g., operational tubes 304,flexible tubes 306, push tubes 308, and support tubes 310, are disposedwithin the minor, secondary, or peripheral lumens in the body structureof the elongate instrument, as illustrated in FIG. 33A and FIG. 33B. Insome embodiments, one or more pull wires 314 may be disposed withinlumens of the support tubes 310, lumens of the flex tubes 306, andlumens of the push tubes 308. As illustrated in FIG. 33A, the distal endor portion of the support tubes 310 may be secured or anchored near thedistal portion of the elongate instrument 300 and the proximal end ofthe support tubes 310 may be slidably coupled to the distal end orportion of the flex tubes 306. In one embodiment, the distal portion ofthe flex tubes 306 may be secured at respective anchor points or regions320 of the elongate instrument 300. Anchoring the flex tubes 306 to theelongate instrument 300 may provide the connections or couplings thatallow force or load to be transferred from the flex tubes 306 to theelongate instrument 300 when force or load is applied to the flex tubes.For example, in some embodiments the flex tubes 306 may be activelycontrolled, that is one or more push tubes 308 or control members 308may be configured to push against respective flex tubes 306. The appliedforce from the push tubes or control members 308 may be transmitted byway of the anchoring points 320 through the flex tubes 306 to theelongated instrument 300. In this way, at least a portion of theelongate instrument 300 may be steered or shaped by the push tubes orcontrol members 308. Similarly, articulation or steering forces or loadsmay be transferred or coupled at the anchor points 320 from one portion(e.g., distal portion) of the elongate instrument 300 to the flex tubes306, such that the flex tubes 306 may act as load bearing supportelements for another portion (e.g., proximal portion) of the elongateinstrument 300 where the force or load may be decoupled or nottransmitted. In other words, the anchor points 320 may function ascoupling points from one portion (e.g., distal portion) of the elongateinstrument 300 to the flex tubes 306 where force or load may betransferred from one portion (e.g., distal portion) of the elongateinstrument to the flex tubes. Similarly, the anchor points 320 may alsofunction as decoupling points between one portion (e.g., distal portion)of the elongate instrument 300 to another portion (e.g., proximalportion) of the elongate instrument 300 where force or load may bedecoupled or not transferred from one portion (e.g., distal portion) ofthe elongate instrument to another portion (e.g., proximal portion) ofthe elongate instrument.

In some embodiments, the location of the anchor points 320 may be variedto control the radius of curvature of a bending section of the elongateinstrument 300 as the elongate instrument is articulated or steered. Insome embodiments, the flex tubes 306 may be anchored at substantiallythe same points or regions of the elongated instrument 300. In someembodiments, the flex tubes 306 may be anchored at substantiallydifferent points or regions of the elongate instrument 300 to affect thebend radius of various portions of the elongate instrument 300 and/orvarious directions of steering or bending. The flex tubes 306 may besecured to the elongate instrument 300 in any suitable manner. In someembodiments, the distal portion of the flex tubes 306 may be fused withthe material of the outer layer or outer tube 302, such as by thermalfusion. Similarly, the material of the outer layer or outer tube 302 maybe fused to the flex tubes 306. For example, the flex tubes 306 may befused to the outer layer or outer tube 302 at various places where it isnot covered by the operational tubes 304, as illustrated in FIG. 33A. Insome embodiments, the elongate instrument may be configured withdisplacement control of the flex members 306. That is, a flex tube 306may not be fixedly coupled to the elongate instrument, instead it may bedisplaced along the length of the elongate instrument 300. Once the flextube 306 is displaced to a desired location, the distal portion of theflex tube 306 may be secured or coupled to the elongate instrument 300by a deployable and retractable anchor. The displacement of proximalportion of the flex tube 306 may be controlled by the push tube orcontrol member 308. The deployable anchor may be deployed to couple theflex tube 306 to a particular anchor point at a particular location onthe elongate instrument. The anchor may also be retracted such that theflex tube 306 may be disengaged or separated from the elongateinstrument 300 such that it may be displaced to a different locationalong the elongate instrument 300.

As illustrated in FIG. 34A, an elongate instrument 300 with passivelycontrolled flex members 300 may be similarly configured as the elongateinstrument structure illustrated in FIG. 33A with the exception that theproximal portion of the flex members 300 may be fixedly coupled to thebody of the elongate instrument, the control unit or splayer (such asthe drivable instrument 182), or some other structural element orcomponent. In some embodiments, the push tube or control member 308 maynot be included as a component of the elongate instrument 300 for apassively controlled flex member. In the passively controlledconfiguration, the flex members 306 may include a service or buffer loop320, as more clearly illustrated in FIG. 34B. The service loop or bufferloop 320 on the flex members 306 may provide the extra service length orbuffer length needed to isolate the articulation loads as the elongateinstrument 300 is pushed through the anatomy, articulated or steered.

As the elongate instrument is pushed through the anatomy, steered orarticulated, the support tubes 310 in the distal section may slide alongthe flex tubes 306 as indicated by the arrows in FIG. 34C. The supporttubes 310 may provide a lumen or path for the pull wires 314 to connectto the distal section of the catheter. The support tubes 310 may alsoprovide some amount of structural rigidity or support to the distalportion of the elongate instrument 300. In some embodiments, theelongate instrument 300 may not include any support tubes 310. In someembodiments, one or more flex tubes 306 may be extended further into thedistal portion of the elongate instrument 300 to provide some structuralrigidity or support to the distal portion of the elongate instrument. Insome embodiments, the flex tubes 306 may be substantially more stiff ormore rigid than the support tubes 310, such that when one or more flextubes 306 are used as support structures to reinforce the distal portionof the elongate instrument 300, the distal portion of the elongateinstrument may be substantially more stiff or more rigid than when it issupported by the support tubes 310. In some embodiments, the flex tube306 may provide substantially the same or similar stiffness orstructural support as the support tubes 310, such that there may not beany significant difference if the flex tubes 306 or support tubes 310are used to provide structural support to the distal portion of theelongate instrument 300. In some embodiments, the flex tubes 306 may besubstantially more flexible than the support tubes 310, such that thedistal portion of the elongate instrument may be substantially moreflexible or less rigid than when it is supported by the flex tubes 306.

Referring back to FIG. 34A, the flex tubes 306 may be slidably coupledto the operational tubes 304 while fixed at the distal end 320. As theelongate instrument 300 is steered or articulated, or as the catheter isadvanced through the natural curvature of the body lumens, the flextubes 306 may slide along the operational tubes 304 as indicated by thearrows illustrated in FIG. 34D. In one scenario, for example, theelongate instrument 300 may be steered by operating or applying tensionto one of the pull wires (e.g., 314A) through operation of one or moregears and/or pulleys in the control unit or splayer. The tension on oneof the pull wires (e.g., 314A) may cause the elongate instrument 300 tobend, as illustrated in FIG. 34D. The inside edge or inside region ofthe bend may be contracted or foreshortened, while the outside edge oroutside region of the bend may be lengthened or stretched. The bend ofthe elongate instrument as described may cause one of the flex tubes(e.g., 306A) to slide “out” near the proximal portion of the elongateinstrument 300 at the contracted or foreshorten edge or region. In thissame example, another one of the flex tubes (e.g., 306B) may slide “in”near the proximal portion of the elongate instrument 300 at thelengthened or stretched edge or region, as illustrated in FIG. 34D. Inorder to accommodate the sliding of “in” and “out” of the flex tubes306, the flex tubes may include a service loop or buffer loop 320 toallow for these “in” and “out” displacements or movements of the flextubes 306. As discussed, the flex tubes 306 may be passively constrainedor restrained. The flex tubes 306 may be constrained or restrained bybeing coupled to the elongate instrument 300, the control unit, orsplayer. In addition, the flex tubes 306 may be constrained orrestrained by hard-stops, tethers, etc. In some embodiments, theoperational tubes 304 may be configured or allowed to float or slidesubstantially freely relative to the outer layer or outer tube 302. Insome other embodiments, the operational tubes 304 may not be configuredor allowed to float or slide substantially freely relative to the outerlayer or outer tube 302.

FIG. 35A through FIG. 35C illustrate the operation of a substantiallyflexible and steerable elongate instrument in accordance with oneembodiment. FIG. 35A illustrates an elongate instrument 300 of aninstrument assembly in a substantially neutral state. In this example,the elongate instrument 300 includes an outer body 302, two sets ofsupport tubes (not shown), operational tubes 304A, 304B, flex tubes306A, 306B, and pull wires 308A, 308B. Each set of support tubes,operational tubes 304A, 304B, flex tubes 306A, 306B, and pull wires 308Aand 308B) may be substantially axially aligned, and the pull wires 308A,308B may be coupled to a control ring (not shown) or mounting pointsthat are located at the distal section or portion of the elongateinstrument 300. As illustrated in FIG. 35A, in the neutral state theflex tubes 306A, 306B and pull wires 308A, 308B may extend out of theoperational tubes 304A, 304B at about the same amount or distance. Asthe substantially flexible and steerable elongate instrument 300 isadvanced into the anatomy and natural pathway (e.g., blood vessel,gastrointestinal tract, etc.) of a patient, it may take on the shape ofthe natural pathway, as illustrated in FIG. 35B. In this example, theproximal section 338 of the elongate instrument may be bent at acurvature induced by the natural pathway (e.g., blood vessel,gastrointestinal tract, etc.), while the distal section 336 may remainrelatively straight or in a substantially neutral state. Due to the bendat the proximal section 338, the flex tube 306A and pull wire 308A mayslide “out” of the operational tube 304A near the inside edge or insideregion of the bend as it may be contracted or foreshortened, asindicated by the arrow illustrated in FIG. 36B. At the same time, due tothe bend at the proximal section 338, the flex tube 306B and pull wire308B may slide “in” to the operational tube 304B near the outside edgeor outside region of the bend as it may be lengthened or stretched, asindicated by the arrow illustrated in FIG. 35B. As may be appreciated,it may be advantageous to maintain the induced shape or curvature of theproximal section 338 of the elongate instrument 300 and at the same timearticulate or steer the distal section 336 of the elongate instrument300 to treat a target site or toward a different direction down thenatural pathway.

In other embodiments of an elongate instrument where flex tube orsimilar control or support structure may not be used, operating ortensioning a pull wire on the outside edge of a bend may cause theelongate instrument to rotate or twist as the pull wire may tend torotate the distal section of the elongate instrument until the pull wireis at the inside edge of the bend; this rotation or twist phenomenon oroccurrence is known as curve alignment.

FIG. 36C illustrates an embodiment of an elongate instrument or catheter300 that does not have coil pipes in the wall of the catheter. When theproximal section of the catheter is curved (as it tracked through curvedanatomy), and the catheter distal section is required to be articulatedin a direction that is not aligned with the curvature in the shaft, awire on the outside of the bend is pulled. A torsional load (T) isapplied to shaft as tension increases on the pull-wire on the outside ofthe bend. This torsional load rotates the shaft until the wire beingpulled is on the inside of the bend. This un-intentional rotation of theshaft causes instability of the catheter tip and prevents the doctorfrom being able to articulate the catheter tip in the direction shown.The phenomenon is known as curve alignment because the wire that isunder tension is putting a compressive force on both the proximal anddistal sections and so both the proximal and distal curvature willattempt to align in order to achieve lowest energy state.

Embodiments described herein may substantially eliminate this problem byproviding support structures such as flex tubes that could prevent curvealignment and substantially prevent or eliminate unwanted rotation ortwist of the catheter. In other words, the pull wires, flex tubes, andthe distal anchor points of the pull wires at the control ring or thebody of the elongate instrument may all be substantially aligned, suchthat operating or tensioning of the pull wires would allow the elongateinstrument to bend in a substantially aligned or neutral configurationwith the longitudinal axis of the pull wire and flex tube. In thisconfiguration, there may not be any component or vector of force or loadthat could cause the elongate instrument to rotate or twist resulting incurve alignment as the elongate instrument is steered or bent.

The design presented in FIG. 36D and with service loops on the proximalend of the coils as per FIG. 34B substantially eliminates or preventscurve alignment and the catheter may be biased, steered, or articulatedin specific planes, e.g., X-Plane, Y-Plane, Z-Plane, of articulation. Byusing flex tubes with service loops as support structures or “backbones”to the catheter shaft, the path length of the wire under tension doesnot change as the proximal shaft is curved. The flex tubes isolate theforces from the proximal section and therefore there is no tendancy tocurve align the distal section with the proximal section and hence norotation of the shaft. In FIG. 36A, as a pull wire is operated(indicated by the arrow) to steer the elongate instrument, the flex tubesupports the pull wire and prevent it from moving to the inside edge ofthe bend, which may produce a force vector that could cause the elongateinstrument to twist or rotate. In this example, the operation of thepull wire causes the distal section of the elongate instrument to besteered or articulated in a substantially upward movement, e.g., thedirection or vector of articulation is in the Y-Plane. Similarly, asillustrated in FIG. 36B, as a pull wire is operated (indicated by thearrow) to steer the elongate instrument, the flex tube supports the pullwire, maintain its alignment to the longitudinal axis, and prevent itfrom moving to the inside edge of the bend, which may produce a forcevector that could cause the elongate instrument to twist or rotate. Inthis example, the operation of the pull wire causes the distal sectionof the elongate instrument to be steered or articulated in a substantialsideway or rightward movement, e.g., the direction or vector ofarticulation is in the X-Plane.

It should be noted that the catheter 300 is not limited to theconfiguration described previously, and that the catheter 300 may haveother configurations in other embodiments.

FIG. 37A illustrates a catheter 412 in accordance with otherembodiments. The catheter 412 has a distal end 430, a proximal end 432coupled to the drivable assembly 182, and a body 434 extending betweenthe distal end 430 and the proximal end 432. In some embodiments, theproximal end 432 is fixedly secured to a hypotube that is in turnfixedly secured to the drivable assembly 182. The catheter 412 has adistal section 436 that articulates in response to control by thedrivable assembly 182 and based on commands received at the workstation2 or the bedside control 402.

FIG. 37B illustrates portion of the catheter 412 in further detail. Asshown in the figure, the distal section 436 of the catheter 412 includesa spine 440 defining a lumen 441 for accommodating an instrument, suchas a guidewire. The spine 440 is configured to provide support for thecatheter 412, and specific bending pivot point for the catheter 412. Thespine 440 may be made from a coil, or a tube with cutout slots toprovide flexibility for the spine 440. As shown in the figure, the spine440 extends partially into the proximal section 438 of the catheter 412.Alternatively, the spine 440 may extend all the way to the proximal end432 of the catheter 412.

The catheter 412 also includes a plurality of coils 442 positionedradially relative to the spine 440. The coils 442 may be used toimplement the flex tubes 306 in some embodiments. The coils 442 areconfigured (e.g., sized and/or shaped) to house respective control wiresthat are attached at their distal ends to a control ring 444, and attheir proximal ends to the drivable assembly 182. In other embodiments,the each tube 306 may not be implemented using the coil 442, and may beimplemented using other elongate elements, such as a continuous tubewith a smooth continuous surface, a wire cage having a tubularconfiguration, etc.

In some embodiments, the control wire coils 442 change coil pitch fromthe distal section 436 to the proximal section 438. In particular, thecoil loops of the coils 442 are more spaced apart at the distal section436, but the coil loops of the coils 448 are closer together at theproximal section 438. Such configuration is advantageous in that itprovides a more flexible distal section 436 so that the distal section436 may be bent to a more tight curve. In one implementation, the coils442 may have an open pitch while the coils 448 may have a closed pitch.In such cases, the coils 448 are wound tightly so that they are in anaturally compressed state. In such configuration, when the steeringwires are pulled in tension, the shaft does not bend and the forces aretransmitted to the proximal end of the catheter. Alternatively, both thecoils 442, 448 may have closed pitch. In some embodiments, each distalcoil 442 and its corresponding proximal coil 448 may be parts of a samecoil structure, wherein the distal portion of the coil structure isconstructed to have coil loops that are more spaced apart than aproximal portion of the coil structure. In other embodiments, the distalcoil 442 may be a separate component that is connected to the proximalcoil 448 (e.g., via a weld, adhesive, etc.).

In some embodiments, the coil 442 is anchored to the distal section 436(e.g., the distal end), while the coil 448 is slidable relative to theproximal section 438. In other embodiments in which the coils 442, 448are parts of a same coil, the coil may be fixed to the catheter body atthe transition between the proximal section 438 and the bendable distalsection 436. In some embodiments, the coil 442 is anchored to the distalsection 436 by anchoring at least a lengthwise portion of a distalportion of the coil 442 to the distal section 436. The lengthwiseportion may be at least 10 mm in some embodiments, and more preferably,at least 20 mm, and even more preferably, at least 30 mm. In otherembodiments, the lengthwise portion may be at least 5% of a combinedlength of the coils 442, 448, and more preferably at least 10%, and evenmore preferably at least 20% of the combined length of the coils 442,448. In other embodiments in which the coils 442, 448 are parts of asame coil, the lengthwise portion may be at least 5% of a total lengthof the coil, and more preferably at least 10%, and even more preferablyat least 20% of the total length of the coil.

During use, the drivable assembly 182 may apply tension to one or morecontrol wires to thereby cause a corresponding bending at the distalsection 436 of the catheter 412. Although two control wire coils 442 forhousing two respective control wires are shown, in other embodiments,the catheter 412 may have only one coil 442 for housing one controlwire, or more than two coils 442 (e.g., four coils 442) for housing morethan two control wires (e.g., four control wires). The control ring 444is embedded within a soft tip 445, which is configured to minimizeinjury to tissue as the catheter 412 is advanced within the patient.

In some embodiments, the catheter 412 further includes an outer jacket446 surrounding the coils 442. The outer jacket 446 is a low durometermaterial for providing flexibility for the articulating distal section436. In some embodiments, the outer jacket 446 may be made from 35D or25D Pebax, or from 70A or 80A Polyurethane. In other embodiments, theouter jacket 446 may be made from other materials as long as the distalsection 436 is sufficiently flexible for it to be articulated.

In some embodiments, the outer jacket material 442 extends partiallyinto the space that is between the loops of the coil 442 (FIG. 37C).Such configuration prevents the control wire from contacting thematerial of the outer jacket material 442, thereby allowing the controlwire to be more easily slide within the lumen of the coil 442. In otherembodiments, the outer jacket material 442 may not extend partially intothe space that is between the loops of the coil 442. Instead, the outerjacket material 442 may be touching only the outer side of the coil 442.This may allow the coils 442 to move relative to the outer jacket 446,thereby improving the flexibility of the distal section 436. In furtherembodiments, the outer jacket material 442 may extend completely intothe space that is between the loops of the coil 442 (FIG. 37D).

The above configurations shown in FIGS. 37C and 37D may be accomplishedthrough a manufacturing process. For example, during a manufacturingprocess, a mandrel may be placed inside the coils 442 to ensure that thelumens remain unobstructed while the jacket is being laminated. Themandrel is then removed post lamination to leave a lumen (through theexpanded coil encased in plastic) that the smaller diameter steeringwire can slide through freely with minimum friction. In someembodiments, by varying the size of the mandrel in the lumen, the amountof encapsulation of the coils 442 with the plastic can be varied. Forexample, a 0.01″ mandrel inside a 0.014″ internal diameter coil willlead to a 0.002″ of plastic inserted in through the coils 448. On theother hand, a 0.014″ mandrel placed inside a 0.014″ coil will ensurethat no plastic encapsulates the inside surface of the coil 442.Limiting the plastic that is inserted through the coils 442 can reducethe friction when the steering wire is pulled since the wire slides morefreely on the coils than on the softer plastic, as discussed. Thus, thecatheter designer can trade off friction in the control wire lumen withstructural integrity of the coils 442 by varying the outer diameter ofthe mandrel used in the manufacturing process.

Also, in some embodiments, during the design of the catheter 412, thepitch of the coil 442 and/or the size of the coil 442 may be selected todefine an amount of maximum bending for the catheter 412. As shown inFIG. 37E, as the distal section 436 of the catheter 412 is being bentdue to a tensioning of a control wire, the coil loops of the coil 442that is housing the control wire will move closer to each other. As aresult, the material 456 of the outer jacket 446 that is between thecoil loops will undergo compression. By varying the pitch of the coil442 during the design of the catheter 412, the amount of material 456between the loops that would undergo compression would vary. Generally,the more material 456 that is between the loops (i.e., more spaced apartloops), the more bending will be allowed for the catheter 412, and viceversa. Also, in other embodiments in which there is no jacket materialbetween the loops of the coil 442, the same design principle may apply.In such cases, the maximum amount of bending for the catheter 412 may beachieved when the distal section 436 is bent so much that the coil loopsof the coil 442 abuts against each other. When the coils 442 abutagainst each other, no further articulation will be possible. Anyadditional force on the control wire will be transmitted directly andfully to the compressed coils 442 rather than the spine or the plasticof the articulation section. This has the benefit of preventingover-articulation that may lead to potential spine fracture, plasticdeformation of the spine, or damage to the distal jacket. Thus, duringthe design of the catheter 412, the loops of the coil 442 may be spacedapart further if more bending is desired for the catheter 412, or spacedcloser if less bending is desired. For example, a coil made of 0.003″wire with a 0.009″ pitch will allow articulation of the catheter 412 toa smaller radius than a coil with a 0.006″ pitch, for example.

In some embodiments, by varying the pitch of the coils 442, the bendshape at the distal section of the catheter 412 may be adjusted. A moreclosely-spaced section of coils (e.g., 0.006″) on the proximal end willresult in a larger minimum radius—i.e., that section will remainstraighter than regions with a larger coil pitch (e.g., 0.009″ pitch) onthe distal end. This technique may be used to get small bend radii atthe very distal end of the catheter 412, which can be used to reachsmall vessels with acute take off angles.

It should be noted that use of the coils 442 as control wire lumens inthe articulating section has several additional advantages. The coils442 have both low axial and bending stiffnesses. This lowersarticulation forces since the lumens on the inside and outside of thebend will more easily contract and expand, respectively. The coils 442also have relatively high radial strength, ensuring that they do notcollapse and pinch the control wire, which would undesirably increasethe wire forces. Also, the coil's 442 ability to expand and contractwill decrease the resistance to bending, and will yield a more uniformbend when compared to traditional polyimide lumen constructions. Inaddition, the coil 442 will provide a load-bearing surface that willradially distribute the control wire load about the jacket. The use ofcoils 442 will also allow the jacket material to be melted around thecoils 442 to thereby secure the coils 442. This will eliminate the needto braid the coils 442 onto a component of the catheter 412. Theelimination of braid will in turn lower the resistance to bending (i.e.,lowering the bending stiffness) because different layers may shiftrelative to each other with a lower force, and will also yield a lowerarticulation force for the catheter 412 and/or smaller bending radiusfor the catheter 412. However, in other embodiments, the coil 442 maystill be braided to a reinforcement layer, such as a wire mesh or aspine. Alternatively, bands of higher durometer (e.g. 72D) crosslinkedPebax may be used to support the expanded coils and fix them to thespine. Cross linked Pebax has improved mechanical properties and greaterdimensional stability and physical toughness compared to regular Pebaxand ensures the coils are adequately fixed to the spine.

Returning to FIG. 37B, as the distal section 436 transitions to theproximal section 438, the material of the outer jacket also changes. Inparticular, proximal to the outer jacket 446, the catheter 412 includesanother outer jacket 454 that is stiffer than the material of the distalouter jacket 446. In some embodiments, the outer jacket 454 may be madefrom a 40D or 55D Pebax. In other embodiments, the outer jacket 454 maybe made from other materials as long as they are stiffer than that ofthe distal outer jacket 446. In further embodiments, the outer jacket454 may be made from the same material as that for the outer jacket 446.In such cases, the outer jacket 446, 450 may be formed together. Thus,the designer may vary the position of the jacket transition relative tothe transition in the coil pipe spacing to get a gradual change instiffness and hence curvature between the proximal and distal sections.This reduces the likelihood of any kink points in the catheter.

As shown in the figure, the proximal section 438 of the catheter 412includes the proximal control wire coils 448. The proximal section 438of the catheter 412 also includes an inner jacket 452 surrounding thecoils 448, and an outer jacket 454 surrounding the inner jacket 452. Insome embodiments, the inner and outer jackets 452, 454 are made fromdifferent materials. In other embodiments, the inner and outer jackets452, 454 may be made from the same materials. Also, in otherembodiments, the inner jacket 452 and/or the outer jacket 454 may bemade from a material that is stiffer than the material for the outerjacket 446 at the distal section 436 and/or the outer jacket at thetransition section. In further embodiments, the inner jacket 452 and/orthe outer jacket 454 may be made from the same material as the outerjacket at the transition section. The embodiments having the outerjacket and the inner jacket allow the designer flexibility to vary thestiffness of the catheter as desired throughout the length of thecatheter, while at the same time ensuring that the steering lumens areencapsulated, that no braid is exposed, and that the structuralintegrity of the shaft is maintained. In addition, in one or more of theembodiments described herein the proximal section 438 of the catheter412 may optionally further include a braid surrounding the coils 448(e.g., embedded within the way of the jacket 452 or jacket 454) forstrengthening and stiffening the proximal section 438. The braid can bestainless steel flat wire or round wire. The braid angle and pic countcan be optimized to give the required stiffness and flexibility. Thebraid may have a constant pattern throughout the proximal section, orthere may be a transition in the braid to enable higher bendingstiffness at the proximal end (compared to the distal end) and higherflexibility at the distal end (compared to the proximal end).

The sheath 414 will now be described. FIG. 38 illustrates the sheath 414in accordance with some embodiments. The sheath 414 includes a bendabledistal section 470, a proximal section 471, and a distal soft tip 472.The distal section 470 that is more flexible than the proximal section471. During use, in response to control by the drivable assembly 184,the distal section 470 will bend based on commands received at theworkstation 2 or the bedside control 402. In some embodiments, theproximal end 471 is fixedly secured to a hypotube that is in turnfixedly secured to the drivable assembly 184.

As shown in FIGS. 39 and 40, the sheath 414 may also include a spine 478in the distal section defining a lumen 441 for accommodating aninstrument, such as the catheter 412. The spine 478 is configured toprovide support for the sheath 414, and specific bending pivot point forthe sheath 414. The spine 478 may be made from a coil, or a tube withcutout slots to provide flexibility for the spine 478.

As shown in FIGS. 38 and 39, the sheath 414 may also include a pluralityof coils 474 positioned radially relative to the spine 478. The coils474 are configured (e.g., sized and/or shaped) to house respectivecontrol wires 475 that are attached at their distal ends to the tip 472,and at their proximal ends to the drivable assembly 184. During use, thedrivable assembly 184 may apply tension to one or more control wires 475to thereby cause a corresponding bending at the distal section 470 ofthe sheath 414. Although four control wire coils 474 for housing fourrespective control wires are shown, in other embodiments, the sheath 414may have less than four coils 474 and control wires 475, or more thanfour coils 474 and control wires 475.

In the illustrated embodiments, the sheath 414 further includes an outerjacket 476 surrounding the coils 474. The outer jacket 476 is a lowdurometer material for providing flexibility for the articulating distalsection 470. In some embodiments, the outer jacket 476 may be made from35D or 55D Pebax, or from 70A or 80A Polyurethane. In other embodiments,the outer jacket 476 may be made from other materials as long as thedistal section 470 is sufficiently flexible for it to be articulated.

In the illustrated embodiments, the control wire coils 474 have an openpitch so that the loops of the coils 474 are spaced apart. Suchconfiguration is advantageous in that it provides a more flexible distalsection 470 so that the distal section 470 may be bent to a more tightcurve. In one implementation, the distal portion of the coil 474 mayhave an open pitch while the proximal portion of the coil 474 may have aclosed pitch. In such cases, the proximal portion of the coil 474 arewound tightly so that they are in a naturally compressed state. In suchconfiguration, when the steering wires are pulled in tension, the shaftdoes not bend and the forces are transmitted to the proximal end of thesheath. Alternatively, the entire length of the coil 474 may have aclosed pitch. In some embodiments, each coil 474 may extend all the wayto the proximal end of the sheath 414. In other embodiments, each coil474 may transition to another coil with a closer loop spacing at theproximal section 471, as similarly discussed with reference to thecatheter 412. In such cases, each distal coil 474 and its correspondingproximal coil may be parts of a same coil structure, wherein the distalportion of the coil structure is constructed to have coil loops that aremore spaced apart than a proximal portion of the coil structure. Inother embodiments, the distal coil 474 may be a separate component thatis connected to the proximal coil (e.g., via a weld, adhesive, etc.).

In the illustrated embodiments, the distal portion of the coil 474 isanchored to the distal section (e.g., the distal end) of the sheath,while the proximal portion of the coil 474 is slidable relative to theproximal section of the sheath. In other embodiments, the coil 474 maybe fixed to the sheath body at the transition between the proximalsection and the bendable distal section.

In some embodiments, the outer jacket material 476 extends partiallyinto the space that is between the loops of the coil 474 (as similarlydiscussed with reference to FIG. 37C). Such configuration prevents thecontrol wire 475 from contacting the material of the outer jacketmaterial 476, thereby allowing the control wire 475 to be more easilyslide within the lumen of the coil 474. In other embodiments, the outerjacket material 476 may not extend partially into the space that isbetween the loops of the coil 474. Instead, the outer jacket material476 may be touching only the outer side of the coil 474. This may allowthe coils 474 to move relative to the outer jacket 476, therebyimproving the flexibility of the distal section 470. In furtherembodiments, the outer jacket material 476 may extend completely intothe space that is between the loops of the coil 474 (as similarlydiscussed with reference to FIG. 37D).

Also, in some embodiments, the pitch of the coil 474 and/or the size ofthe coil 474 may be selected to define an amount of maximum bending forthe sheath 414. As similarly discussed with reference to FIG. 37E, asthe distal section 470 of the sheath 414 is being bent due to atensioning of a control wire, the loops of the coil 474 that is housingthe control wire 475 will move closer to each other. As a result, thematerial of the outer jacket 476 that is between the coil loops willundergo compression. By varying the pitch of the coil 474 during thedesign of the sheath 414, the amount of material between the loops thatwould undergo compression would vary. Generally, the more the materialthat is between the loops (i.e., more spaced apart loops), the morebending will be allowed for the sheath 414, and vice versa. Also, inother embodiments in which there is no jacket material between the loopsof the coil 474, the same design principle may apply. In such cases, themaximum amount of bending for the sheath 414 may be achieved when thedistal section 470 is bent so much that the coil loops of the coil 474abuts against each other. Thus, during the design of the sheath 414, thecoil loops of the coil 474 may be spaced apart further if more bendingis desired for the sheath 414, or spaced closer if less bending isdesired.

In the above embodiments, the coils 474 are surrounded by the outerjacket 476, which functions to contain the coils 474 during use. Inother embodiments, the sheath 414 may further include a braided layer480 for reinforcing the structure of the sheath 414 (FIGS. 41 and 42).In such cases, the coils 474 for housing the control wires 475 may becoupled to the braided layer. As shown in FIG. 42, in some embodiments,the coils 474 may be coupled to the outer surface of the braided layer480, e.g., by wrapping part of the coils 474 around the braided layer480, by attaching them using adhesive, etc. In other embodiments, thecoils 474 may be coupled to the inner surface of the braided layer 480(FIG. 41), e.g., by wrapping part of the coils 474 around the braidedlayer 480, by attaching them using adhesive, etc. In one approach, thecoils 474 are braided by looping around the coil at the section closestto the sheath body, so that the braid will not tent over the coil. Thisbraiding method eliminates the potential for the braid to apply loads onthe control wires. This braiding approach will also minimize the coilsnatural tendency to peel away from the sheath 414 when high articulationforces are used, or when the jacket is made from a material with lowdurometer.

As shown in FIG. 43, in some embodiments, different sections along thelength of the sheath 414 may have different configurations to achievedifferent stiffnesses. In the implementation shown, the sheath 414includes a HDPE liner and two layers of stainless steel braid thatextend all the way from the drivable assembly 184 to the distal end ofthe sheath 414. The liner is a coextrusion of HDPE and plexar. Theplexar is a tie layer and its purpose is to ensure that the liner isproperly bonded to the outer jacket extrusions. The distal 27 mm of thebraid on the top layer is 100 ppi while the remainder of the top braidis at 40 ppi. In other embodiments, the pic count of the braid may alsochange on the bottom layer. This allows for increased stiffness in theproximal section and increased flexibility at the distal section (e.g.,the distal 27 mm length) without increasing the risk of kinking. Thelength of the 100 ppi section can be longer or shorter than 27 mm to agive longer or shorter distal segment. In addition, the outer jackettransitions from a relatively stiff 70D pebax (not shown) in thetracking section of the sheath to 55D Pebax for a 10 cm region at thetransition to the bending section. This is then followed byapproximately 25 mm of articulation region. This change in durometer ofthe outer jacket, combined with the change in braid coverage contributeto a sharp change in stiffness in the articulation region which enablesa 90° or more articulation angle to be achieved.

As shown in FIG. 44, the spine 478 and/or the braided layer 480 of thesheath 414 may have a square cross section in at least a section alongthe length of the sheath 414. In such cases, the coils 474 and thecontrol wires 475 may be placed next to the straight side of the squarecross section. Such configuration allows more of the jacket material 476to be surrounding the coils 474, thereby reducing the risk that thecoils 474 may cut through the jacket material 476 due to the tensioningof the control wires 475.

It should be noted that use of the coils 474 as control wire lumens inthe articulating section has several additional advantages. The coils474 have both low axial and bending stiffnesses. This lowersarticulation forces since the lumens on the inside and outside of thebend will more easily contract and expand, respectively. The coils 474also have relatively high radial strength, ensuring that they do notcollapse and pinch the control wire, which would undesirably increasethe wire forces. Also, the coil's 474 ability to expand and contractwill decrease the resistance to bending, and will yield a more uniformbend when compared to traditional polyimide lumen constructions. Inaddition, the coil 474 will provide a load-bearing surface that willradially distribute the control wire load about the jacket. The use ofcoils 474 will also allow the jacket material to be melted around thecoils 474 to thereby secure the coils 474. This will eliminate the needto braid the coils 474 onto a component of the sheath 414. Theelimination of braid will in turn lower the resistance to bending (i.e.,lowering the bending stiffness) because different layers may shiftrelative to each other with a lower force, and will also yield a lowerarticulation force for the sheath 414 and/or smaller bending radius forthe sheath 414. However, in other embodiments, if the anchor strength ofthe coil 474 is desired to be improved, the coil 474 may still bebraided to a reinforcement layer, such as a wire mesh or a spine.

In one or more of the embodiments of the catheter 412 and the sheath 414described herein, the catheter 412 and/or the sheath 414 may not includeany spine structure and/or any braided layer. This may have the benefitof further improving the flexibility of the catheter 412 and/or thesheath 414 at the articulating section.

To illustrate the benefits of the configurations of the catheter 412 andthe sheath 414 described herein, a method of reaching a target regionusing a catheter and a sheath will be described. In particular, FIG. 45shows a catheter C inserted in the right common femoral artery. The tipof the sheath C is positioned in the right common iliac artery and thecatheter C is extended from the tip of the sheath to reach the iliacbifurcation. Next, the steerable distal section of the catheter C ispulled back and articulated towards the left common iliac artery and theguidewire G is advanced out from the tip of the catheter C. Theguidewire G is then advanced towards the left external iliac artery.Once the guidewire G is advanced far enough to provide sufficientsupport for the catheter C, the control wires in the catheter C can beslacked (by removing tension in the control wires). This lowers thedistal stiffness, and allows the catheter C to track more easily overthe guidewire. If the catheter C is advanced distally at this point, thecatheter C may sometimes follow the guidewire G over the bifurcation andinto the left common iliac artery (as illustrated by the dashed path).However, in some patients with tight iliac bifurcations, the catheter Cmay not follow the guidewire G, but instead will prolapse up into theaorta. The force applied at the point of insertion is in the directionof the aorta, and so the catheter C may tend to move in that direction.

By providing the sheath 414 with the features described herein, thesheath 414 can be advanced forward and the distal articulation sectionof the sheath 414 can be articulated towards the left common iliac (FIG.46) to support the leader. Once the sheath 414 is in this position, theshape of the sheath 414 can be locked by maintaining tension on thecontrol wires. Next, the catheter 412 can be advanced, and the catheter412 will deflect off the sheath 414 (rather than the artery wall), andcan be advanced into the left common iliac (instead of prolapsing upinto the aorta). As the catheter 412 is advanced through the deflectedsheath 414, the tension on the control wire(s) of the catheter 412 isremoved, and the distal steering section of the catheter 412 is allowedto straighten or to conform to whatever shape imposed by the shape ofthe sheath 414. As such, the shaft of the catheter 412 will followthrough the articulated sheath 414. The articulated sheath 414 functionslike a pre-shaped or curved lumen for the catheter 412 to be advancedtherethrough. Since the sheath 414 provides the support to direct thepath of the catheter 412 over the bifurcation, no tension is required onthe control wires of the catheter 412 to track over the bifurcation inthis example. Therefore, even if the iliac bifurcation is at a verytight angle (in some cases up to 180°), the catheter 412 can still beadvanced through the sheath lumen without placing any stress or shearingforces on the wall of the artery. The insertion force may increase onthe catheter 412 as the bifurcation angle gets tighter, but the loadsare being applied to the inside of the sheath 414, and not to thepatient anatomy. In some embodiments, the steerable sheath 414 may beadjusted to ensure that its position and/or shape can be maintained onthe sheath distal section as the catheter 412 is advanced through thesheath 414. For example, the instrument driver assembly 408 maycompensate for the increased load by pulling more on the control wiresor slightly withdraw the sheath 414 to ensure that the sheath 414 willnot damage the artery wall. In some embodiments, during the procedure,the inner surface of the sheath 414 and/or the outer surface of thecatheter 412 may optionally be coated with a lubricous coating.

As illustrated in the above example, the sheath 414 or leader may bearticulated to have a tight bend during a procedure. Embodiments of thesheath 414 and leader described herein allow this to happen. Inparticular, the control wire coils 474 in the sheath 414 or leaderisolate the articulation loads from the shaft, thereby allowing thesheath 414 or leader shaft to be manufactured from low durometerflexible materials. As a result, the articulation loads are resolved viathe control wire coils 474 which have a relatively high axial stiffnessand low bending stiffness. These control wire coils 474 allow the distalsection of the sheath 414 or leader to be articulated to a small radius,and at the same time, the proximal section of the sheath 414 or leadercan be maintained very flexible.

FIGS. 47 and 48 illustrate another method for advancing the sheath 414and the catheter 412 over the iliac bifurcation. In this technique, thecatheter 412 is positioned with its distal articulation sectiontraversing the iliac bifurcation and it is locked in this position.Embodiments of the catheter 412 described herein allows the catheter 412to reach tight angle that may be encountered during the procedure. Next,the sheath 414 is advanced over the catheter 412, and the catheter 412acts as a rail held in a fixed shape for the sheath 414 to glide over.As the sheath 414 is advanced further, sections with higher bendingstiffness on the sheath 414 will pass over the articulated section ofthe catheter 412, putting an increase load on the catheter 412. Theincrease in load on the catheter 412 may tend to straighten the catheter412. Embodiments of the catheter 412 described herein allows thecatheter 412 to maintain its bent shape by tightening the controlwire(s), which has the effect of stiffening the catheter 412. In someembodiments, the robotic system is configured to detect the increasedload on the control wires (due to the placement of the sheath 414 overthe catheter 412) to be detected. The operator, or the robotic system,can then apply an equal counteracting load on all the control wires ofthe catheter 412 to ensure that its bent shape is maintained while thesheath 414 is advanced over the iliac bifurcation.

The doctor can continue to advance the catheter 412 through thearticulated sheath 414. He can continue to steer the tip of the catheter412 to access the required points of interest in the patient's left leg(FIG. 48). In particular, FIG. 48 shows how the catheter 412 can bearticulated to reach the left internal iliac artery. This articulationof the catheter 412 is carried out simultaneously with the continuedinsertion of the catheter 412. This requires the shaft of the catheter412 to remain flexible at all times even when high articulation loadsare being applied to bend the articulation section. Embodiments of thecatheter 412 described herein allow this to happen. In particular, thecontrol wire coils 442 in the catheter 412 isolate the articulationloads from the catheter shaft, thereby allowing the catheter 412 shaftto be manufactured from low durometer flexible materials. As a result,the articulation loads are resolved via the control wire coils 442 whichhave a relatively high axial stiffness and low bending stiffness. Thesecontrol wire coils 442 allow the distal section of the catheter 412 tobe very bendable, and at the same time, the proximal section of thecatheter 412 can be maintained very flexible. Also, in some cases, thedesign of the catheter 412 described herein obviates the need tomaintain the proximal section of the catheter 412 to be straight duringuse, which may be the case with some existing catheters. In particular,the embodiments of the catheter 412 described herein allow high degreesof bendability at the distal section of the catheter 412 while alsoallowing a flexible proximal and middle segments. This achievesconsistent bending at the distal section of the catheter 412 which isindependent of the shape of the proximal section of the catheter 412.

As illustrated in the above embodiments, the catheter design isadvantageous over existing catheters. In steerable catheters, when thesteering wire in the wall of a catheter is pulled, a pull force F_(p) isapplied through the centre line of the pullwire. A reaction force isthen generated by the catheter body to resist this pull force. Thisreaction force F_(r) is typically applied uniformly around the body orcircumference of the catheter. The summation of the reaction force F_(R)is applied on the center line of the catheter. The offset between thepull force and the reaction force generates a moment at the tip of thecatheter. This moment is what causes the catheter to bend. In somecatheters in which the entire length of a catheter is built with auniform bending stiffness, then the entire catheter would benduniformly. Such configuration does not result in bending of the distalsection only. Some other existing catheters have attempted to addressthis issue by substantially increasing the bending stiffness in theproximal section of the catheter and leaving the distal section of thecatheter very flexible. In this situation, when the wire is pulled, theproximal section bends only slightly (because it is stiffer) and themajority of the displacement occurs at the softer distal section. Whilethis solution (of stiffening the proximal end) is applicable for somecatheters, it will not work where the proximal section of the catheteris required to remain very flexible to traverse through tortuous anatomysuch as in vascular applications. Each of the steering wires are offsetfrom the center line of the catheter and so when the wires are tensionedto steer the catheter tip, the resulting compressive forces on aflexible catheter shaft cause unwanted stiffening of the catheter shaft,especially in the proximal section, which is undesirable. Othersteerable catheters and endoscopes attempt to overcome this problem bymoving the pull wires to the center of the catheter at the proximalsection. By moving the pullwires to the centerline of the catheter,unwanted deflection in the shaft is eliminated, and stiffening of thecatheter at the proximal section is somewhat reduced. However, thissolution will not work in situation in which an open lumen down thecenter of the catheter is required.

Embodiments of the catheter design described herein addresses all of theabove problems and is specifically applicable for catheters that require(1) significant articulation performance at the distal end, (2) a veryflexible catheter shaft (especially at the proximal section), and (3) anopen lumen through the middle of the catheter to deliver therapy orother devices. The design involves putting an axially stiff tube (e.g.,coil) into the wall of the shaft and using this tube to isolate thesteering loads from the catheter shaft. As a steering wire is pulled,the reaction load F_(r) is applied uniformly by the wall of the coil,and the summation of the reaction force is now applied through thecenter of the coil pipe and not the center of the catheter. The proximalsection of the coil may be tightly wound to take the reaction force.Because of this, the pull force F_(p) of the steering wire and thereaction force F_(R) by the coil are collinear and there is no momentgenerated in the proximal section of the catheter. The coil in thedistal section remains loosely wound so it does not take any axial loadand applies no reaction force. Therefore, the reaction force at thedistal section of the catheter will continue to be applied about thecenterline (or cross sectional centroid) of the catheter. This ensuresthat there is a moment generated at the distal section of the catheterand so the tip continues to bend when a pull force is applied to thewire. The additional benefit of placing an axially stiff member in thewall of the catheter is that it shifts the neutral axis from thecatheter cross sectional centroid to the cross sectional centroid of thecoil. There is significant benefit for articulation consistency when thepullwire is on the neutral axis. Therefore, this design biases theneutral axis of the catheter to make it collinear with a pullwire in thewall at the proximal section. The above design allows the catheter shaft(at least the proximal section) to be made from very flexible material.This ensures that the proximal section of the catheter can freely bendindependently to fit through tortuous anatomy, regardless of how thedistal section is steered.

In the above procedures, the catheter 412 and the sheath 414 worktogether in a telescoping motion to minimize stress on the wall of thearteries. Although the procedure is described with reference totraversing a tight iliac bifurcation, in other embodiments, the similartechnique may be used to access other locations in the patient. Forexample, in other embodiments, similar technique may be used to accesscarotid arteries with tight take off angles from the aortic arch.

In some embodiments, after the catheter 412 has been driven to a desiredlocation, a valve (shown in FIG. 49) on the proximal end of the catheter412 or sheath may be tightened, and the doctor may then inject contrastthrough the catheter 412 or sheath to perform a selective angiogram ofthe region of interest. The passive hemostatic seal on the proximal endof the sheath is supported by a Touhy Borst fitting on the illustratedembodiment to ensure that it can maintain the high injection pressures.Once the contrast injection is complete, the Touhy Borst fitting isloosened and the passive valve continues to ensure hemostasis againstthe surface of the guidewire. FIGS. 50A-50C show the Touhy Borst valvein further details. In particular, FIGS. 50A and 50B illustrate frontand back perspective views of a valve assembly 484 which is configuredto be coupled at its distal end to a support tube 483 and configured toreceive the guide wire 482 co-axially at its proximal end. FIG. 50Cillustrates an exploded view of the valve assembly 484 including a tubenut 485, a flush joint 486, a passive valve 487, a cap 488, a valve body489, a Touhy Borst body 490, a Touhy Borst seal 491, and a Touhy Borstnut 492. The passive valve 487 has a slit that is configured to holdhemostasis when nothing is inserted therethrough. The cap 488 has a holethat is configured to hold hemostasis when a wire or a catheter isinserted through it. The support tube 483 which can be coupled to theguide catheter (not shown) at its distal end can be inserted into theflush joint 486 and locked into position by tightening the tube nut 485.The guide wire 482 can be inserted through the proximal end of the TouhyBorst nut 492 and through the central lumen of the remainder of thevalve assembly 484 eventually being fed co-axially into the support tube483 and ultimately the guide catheter. Alternatively, the Touhy Borstcan be tightened onto the leader catheter to facilitate contrastinjection through the sheath. The Touhy Borst nut 492 is tightened tocompress the Touhy Borst seal 491 into a sealed or completely sealedposition. During operation, fluid may be introduced through a flush port493 on the flush joint 486. The passive valve 487 acts as a one-wayvalve which allows the guide wire 482 to be inserted towards the distalend of the valve assembly 484 but prevents fluid from flowing towardsthe proximal end of the valve assembly. Thus the pressurized fluid isforced to flow through the support tube 483, and the flush of contrastis delivered to the region of the vasculature. The Touhy Borst seal 491may be used as a secondary seal in the case where high pressure fluid isintroduced which cannot be contained by the passive seal 487. In one ormore of the embodiments described herein, the valve may be adjustablesuch that it will seal automatically as the contrast injection pressureis being applied. Also, in other embodiments, instead of using a TouhyBorst valve, other types of valve may be used.

Also, in some embodiments, once the guide wire 482 has been positioneddistal of a stenosis in an artery, the catheter 412 can be withdrawncompletely from the sheath 414, leaving the wire 482 and the sheath 414in place. Next, a therapy of choice can be selected, and delivered overthe wire 482 to the site of interest. By means of non-limiting examples,the therapy can range from balloon expandable stents, self expandingcovered and/or uncovered stent, as well as a range of artherectomydevices that can traverse over the wire 482. As the therapy is beingdelivered, the user continues to have the ability to steer the distalend of the sheath 414 to help ensure that the therapy can be deliveredto the desired location. For example, as the therapy is being deliveredthrough the anatomy, the sheath 414 may tend to move away from thetarget location. The doctor can adjust tension on the control wires ofthe sheath 414 as required to compensate for this movement and ensurethat the therapy will reach the required location.

III. Bedside Configuration

FIGS. 51A-51F illustrate another robotic surgical system 400 inaccordance with other embodiments. The robotic surgical system 400 issimilar to the embodiment described previously, except that it furtherhas both a bed-side control 402 and a bed-side display (not shown). Thebed-side control 402 is configured to provide some or all of thefunctions that the workstation can provide, so that the physician canperform most robotic catheter control tasks at either the workstation orthe bed-side.

The system 400 also includes a setup mount (setup joint) 404 that issimilar to that discussed previously. However, in the illustratedembodiments, the setup mount 404 is mounted to the patient support 22via a rail system 406. The rail system 406 allows the setup mount 404(and therefore, the instrument driver assembly 16) to translate alongthe length of the patient support 22. In some embodiments, the railsystem 406 includes a motorized rail 407, that can be actuated to drivemovement of the setup mount 404. In other embodiments, other mechanismsmay be used, including but not limited to a lead screw, a ball screw,linear motor, belt, and/or cable drive, etc. The movement of the setupmount 404 along the rail may be caused by entering a command at theworkstation, or at the bedside control 402. In other embodiments, thesetup mount 404 may be allowed to move by actuating a button at thesetup mount 404, thereby releasing the setup mount 404 from a lockedposition against the rail system 406. The setup mount 404 can then betranslated manually along the axis of the patient support 22. When thesetup mount 404 has reached a desired position, the button may bereleased to lock the setup mount 404 at the desired position. Setupmount/joint has been described in U.S. Pat. No. 7,789,874, filed on Jul.1, 2005, the entire disclosure of which is expressly incorporated byreference herein. Alternatively, the movement of the setup mount 404along the rail may be controlled using the workstation 2 and/or thebedside control 402. In one or more of the embodiments described herein,any of the controls, including release lever/button, may be implementedat any location, such as at the bedside control 402, at the workstation2, on the side opposite from the side at which the bedside control 402is located, etc. Also, in some embodiments, two release levers/buttonsmay be provided, with one located on the doctor's side (e.g., at thebedside control 402), and another one on the back side for ease ofservice and safety.

Also, in other embodiments, the rail system 406 may be configured totilt the setup mount 404 (as illustrated by the arrows in FIG. 51G) inresponse to command entered at the workstation 2 and/or the bedsidecontrol 402. In some cases, the tilting range of the angle can be up to20° or higher. Such configuration allows the insertion trajectory of thecatheter 412 and/or the sheath 414 to be tilted (e.g., relative to thebed). In other embodiments, the rail system 406 may be configured tomove in other directions in other degrees of freedom. For example, inother embodiments, the rail system 406 may move up and down to adjustthe height, and/or laterally towards either side of the bed. In furtherembodiments, the rail system 406 may roll (e.g., tilted about itslongitudinal axis). Also, in one or more of the embodiments describedherein, there may be an angular motion or indexed tilt of the rail aboutany axis to better align with the catheter insertion, and compensate forany sagging of the catheter or an anti-buckling device (which isdescribed herein). In further embodiments, the rail system 406 may havea 10 degree angle (or other angles) incline. In the embodiments shown inFIG. 51A, the rail shark fin (the triangular plate on one side of thebed) is configured to allow adjustment of the rail incline in 5 degreeincrements up to 20 degrees.

The robotic system 400 also includes an instrument driver assembly 408.The instrument driver assembly 408 includes a catheter drivable assembly182 for positioning a catheter 412, and a sheath drivable assembly 184for positioning a sheath 414 that is placed coaxially around thecatheter 412. The instrument driver assembly 408 is similar to thatdiscussed previously. In the illustrated embodiments, the sheathdrivable assembly 184 is moveable relative to the catheter drivableassembly 182. Each of the drivers 82, 84 has four drivable elements formoving the catheter 412, and the sheath 414, respectively, in differentdirections. In other embodiments, the number of drivable elements ineach of the drivers 82, 84 may be less than four or more than four. Theinstrument driver assembly 408 also includes two anti-buckling devices500 a, 500 b for preventing the buckling of the catheter 412, and thebuckling of the sheath 414 during use. The anti-buckling devices will bedescribed in further detail below. The instrument driver assembly 408further includes a guide wire manipulator 410 for positioning aguidewire (not shown) that may be placed within a lumen of the catheter412.

IV. Driving Modes and Clinical Applications

The instrument driver assembly 408 may be configured to move the sheath414 distally or proximally, move the catheter 412 distally orproximally, and to move the guidewire distally or proximally. In somecases, the movement of the sheath 414 may be relative to the catheter412, while the catheter 412 remains stationary. In other cases, themovement of the catheter 412 may be relative to the sheath 414 while thesheath 414 remains stationary. Also, in other cases, the sheath 414 andthe catheter 412 may be moved together as a unit. The guidewire may bemoved relative to the sheath 414 and/or the catheter 412. Alternatively,the guidewire may be moved together with the sheath 414 and/or thecatheter 412.

In some embodiments, each of the workstation 2 and the bedside control402 is configured to provide some or all of the following commandedmotions (driving modes) for allowing the physician to choose. In someembodiments, each of the driving modes may have a corresponding buttonat the workstation 2 and/or the bedside control 402.

Guidewire Insert—When this button/command is selected, the guide wiremanipulator 410 inserts the guidewire at a constant velocity.

Guidewire Roll—When this button/command is selected, the guide wiremanipulator 410 rolls the guidewire at a constant angular velocity

Guidewire Size—When the size or gauge of the guidewire is inputted intothrough the user interface, the system will automatically alter roll andinsert actuation at the proximal end of the guidewire accordingly toachieve desired commanded results. In one implementation, when a userinputs the guidewire size, the system automatically changes itskinematic model for driving that guidewire. So if the user commands aguidewire to move to a certain position, the system will calculate,based on the kinematic model, roll and insert commands, which may bedifferent for different guidewire sizes (e.g., guidewires with differentdiameters). By inputting the guidewire size, the system knows whichkinematic model to use to perform the calculation. Such feature isbeneficial because different sized guidewires behave differently.

Leader/Sheath Select—When this button/command is selected, it allows theuser to select which device (e.g., catheter 412, sheath 414, guidewire,or any combination of the foregoing) is active.

Leader/Sheath Insert/Retract—When this button/command is selected, theinstrument driver assembly 408 inserts or retracts the catheter412/sheath 414 while holding the guidewire and any non-active devicefixed relative to the patient. When this motion causes the protrudingsection of the catheter 412 to approach zero (due to insertion of thesheath 414 or retraction of the catheter 412), the system automaticallyrelaxes the catheter 412 as part of the motion.

Leader/Sheath Bend—When this button/command is selected, the instrumentdriver assembly 408 bends the articulating portion of the catheter412/sheath 414 within its currently commanded articulation plane.

Leader/Sheath Roll—When this button/command is selected, the instrumentdriver assembly 408 uses the pullwires to “sweep” the articulation planeof the device (catheter 412 and/or sheath 414) around in a circlethrough bending action of the device. Thus, this mode of operation doesnot result in a true “roll” of the device in that the shaft of thedevice does not roll. In other embodiments, the shaft of the device maybe configured to rotate to result in a true roll. Thus, as used in thisspecification, the term “roll” may refer to an artificial roll createdby seeping a bent section, or may refer to a true roll created byrotating the device.

Leader/Sheath Relax—When this button/command is selected, the instrumentdriver assembly 408 gradually releases tension off of the pullwires onthe catheter 412/sheath 414. If in free space, this results in thedevice returning to a straight configuration. If constrained in ananatomy, this results in relaxing the device such that it can mosteasily conform to the anatomy.

Guide Wire Lock—When this button/command is selected, the guide wireposition is locked to the leader position. As the leader is articulatedor inserted, the guide wire moves with the leader as one unit.

System Advance/Retract—When this button/command is selected, theinstrument driver assembly 408 advances/retracts the catheter 412 andsheath 414 together as one unit. The guidewire is controlled to remainfixed relative to the patient.

Autoretract—When this button/command is selected, the instrument driverassembly 408 starts by relaxing and retracting the catheter 412 into thesheath 414, and then continues by relaxing and retracting the sheath 414with the catheter 412 inside it. The guidewire is controlled to remainfixed relative to the patient.

Initialize Catheter—When this button/command is selected, the systemconfirms that the catheter 412 and/or the sheath 414 has been properlyinstalled on the instrument driver assembly 408, and initiatespretensioning. Pretensioning is a process used to find offsets for eachpullwire to account for manufacturing tolerances and the initial shapeof the shaft of the catheter 412 and/or the sheath 414.

Leader/Sheath Re-calibration—When this button/command is selected, theinstrument driver assembly 408 re-pretensions the catheter 412 and/orthe sheath 414 in its current position. This gives the system theopportunity to find new pretension offsets for each pullwire and canimprove catheter driving in situations where the proximal shaft of thecatheter 412 has been placed into a significant bend such as aftercrossing the illiac bifurcation. It is activated by holding a relaxbutton down for several seconds which ensures that the device is fullyde-articulated. Alternatively the re-calibration may be activatedwithout holding down the relax button to de-articulate the device.

Leader Relax Remove—When this button/command is selected, the instrumentdriver assembly 408 initiates a catheter removal sequence where thecatheter 412 is fully retracted into the sheath 414, all tension isreleased from the pullwires, and the splayer shafts (at the drivableassembly 182 and/or drivable assembly 184) are driven back to theiroriginal install positions so that the catheter 412 can be reinstalledat a later time.

Leader Yank Remove—When this button/command is selected, the instrumentdriver assembly 408 initiates a catheter removal sequence where theleader is removed manually.

Emergency Stop—When this button/command is selected, the instrumentdriver assembly 408 initiates a gradual (e.g., 3 second) relaxation ofboth the catheter 412 and the sheath 414. The components (e.g.,amplifier) for operating the catheter 412, guidewire, or another deviceare placed into a “safe-idle” mode which guarantees that no power isavailable to the motors that drive these elements, thereby bringing themrapidly to a stop, and allowing them to be manually back-driven by theuser. Upon release of the emergency stop button, the system ensures thatthe catheter 412 is still in its allowable workspace and then returns toa normal driving state.

Segment control: In some embodiments, the workstation 2 and/or thebedside control 402 allows a user to select individual segment(s) of amulti-segment catheters (such as the combination of the catheter 412 andthe sheath 414), and control each one. The advantage of controlling thecatheter in this way is that it allows for many options of how tocontrol the movement of the catheter, which may result in the mostdesirable catheter performance. To execute this method of cathetersteering, the user selects a segment of the catheter to control. Eachsegment may be telescoping or non-telescoping. The user may then controlthe selected segment by bending and inserting it using the workstation 2and/or the bedside control 402 to control the position of the end pointof the catheter. Other segment(s) of the catheter will either maintaintheir previous position (if it is proximal of the selected section) ormaintain its previous configuration with respect to the selected section(if it is distal of that section) (FIG. 52A).

Follow mode: In some embodiments, the workstation 2 and/or the bedsidecontrol 402 allows the user to control any telescoping section while themore proximal section(s) follows behind automatically. This has theadvantage of allowing the user to focus mostly on the movement of asection of interest while it remains supported proximally. To executethis method of catheter steering, the user first selects a telescopingsection of the catheter to control. This section is then controlledusing the workstation 2 and/or the bedside control 402 to prescribe alocation of the endpoint of the segment. Any segment(s) distal of thesection of interest will maintain their previous configuration withrespect to that section. When the button on the workstation 2 or thebedside control 402 is released, any segment(s) proximal of the sectionof interest will follow the path of the selected section as closely aspossible until a predefined amount of the selected section remains (FIG.52B). As an alternative to this driving mode, the segment(s) of thecatheter which is proximal of the section of interest could follow alongas that segment is moved instead of waiting for the button to bereleased. Furthermore, with either of these automatic follow options,the system may optionally be configured to re-pretension the sectionsthat have been driven out and re-align the sections that are proximal ofthe driven section.

Follow mode may be desirable to use to bring the more proximal segmentsof the catheter towards the tip to provide additional support to thedistal segment. In cases where there are three or more controllablesections of the catheter, there are several options for how to execute a“follow” command. Consider the example in FIG. 52D where the distalsegment has been driven out as shown in frame 1. The “follow” commandcould be executed by articulating and/or inserting only the middlesegment of the catheter as shown in frame 2. The “follow” command couldbe executed by articulating and/or inserting only the most proximalsegment of the catheter as shown in frame 3. The “follow” command couldalso be executed by coordinating the articulation and/or insertion ofmultiple proximal segments of the catheter as shown in frame 4.Combining the motion of multiple sections has several potentialadvantages. First, it increases the total degrees-of-freedom availableto the algorithm that tries to fit the shape of the following section(s)to the existing shape of the segment being followed. Also, in comparisonto following each segment sequentially, a multi-segment follow modesimplifies and/or speeds up the workflow. In addition, multi-segmentincreases the distance that can be followed compared to when only oneproximal segment is used to follow the distal segment.

Mix-and-match mode: In some embodiments, the workstation 2 and/or thebedside control 402 allows the user to have the option of mixing andmatching between articulating and inserting various sections of acatheter. For example, consider the illustration in FIG. 52C, andassuming that the distal most section of the catheter is the “active”segment. If the user commands a motion of the tip of the catheter asindicated by the arrow in Frame 1, there are several options availablefor how to achieve this command: (1) Articulate and extend the “active”segment, which is illustrated in frame 3 and is likely considered thenormal or expected behavior; (2) Articulate the active distal mostsegment and insert one of the other proximal segments, as illustrated inframes 2 and 4; (3) Articulate the active distal most segment andcombine inserting motion of some or all of the segments, as illustratedin frame 5.

There are multiple potential reasons why the user might want to choosesome of these options. First, by “borrowing” insert motion from othersegments, some of the segments could be constructed with fixed lengths.This reduces the need for segments to telescope inside of each other,and therefore reduces the overall wall thickness. It also reduces thenumber of insertion degrees-of-freedom needed. Also, by combining theinsert motion from several segments, the effective insertrange-of-motion for an individual segment can be maximized. In aconstrained space such as the vasculature, the operator may likely beinterested in “steering” the most distal section while having as mucheffective insertion range as possible. It would simplify and speed upthe workflow to not have to stop and follow with the other segments.

Locking mode: In some embodiments, the workstation 2 and/or the bedsidecontrol 402 may be configured to allow any of the section (e.g.,proximal section) of a catheter to be “locked” into a given shape. Somedriving modes that may take advantage of such feature include: (1)Locking the proximal segment into its current shape after each motion ofthe proximal segment is executed. The proximal section would then unlockwhenever it is given another follow motion command. These motioncommands would be either direct driving of the most proximal section orfollowing of the more distal sections. (2) Leave the proximal sectionflexible for insertion by hand, then lock the proximal section once thecatheter is attached to the robotic system. The proximal section couldthen be unlocked again for further manual insertions, either by removingthe catheter from the instrument driver assembly 408 or by releasing thebrake on the setup joint 404. For any of these options, the lockingportion could be: (1) The proximal (actively) articulating segment, (2)some or all of the “body” of the catheter proximal of the activelyarticulating segments, or (3) both the proximal actively articulatingsegment and some portion of the non-articulating “body” of the catheter.

In other embodiments, the “follow” mode may be carried out using arobotic system that includes a flexible elongated member (e.g., aguidewire), a first member (e.g., the catheter 412) disposed around theflexible elongated member, and a second member (e.g., the sheath 414)disposed around the first member. The flexible elongated member may havea pre-formed (e.g., pre-bent) configuration. In some embodiments, theflexible elongated member may be positioned inside a body. Such may beaccomplished using a drive mechanism that is configured to position(e.g., advance, retract, rotate, etc.) the flexible elongated member. Inone example, the positioning of the flexible elongated member comprisesadvancing the flexible elongated member so that its distal end passesthrough an opening in the body.

Next, the first member is relaxed so that it has sufficient flexibilitythat will allow the first member to be guided by the flexible elongatedmember (that is relatively more rigid than the relaxed first member). Insome embodiments, the relaxing of the first member may be accomplishedby releasing tension in wires that are inside the first member, whereinthe wires are configured to bend the first member or to maintain thefirst member in a bent configuration. After the first member is relaxed,the first member may then be advanced distally relative to the flexibleelongated member. The flexible elongated member, while being flexible,has sufficient rigidity to guide the relaxed first member as the firstmember is advanced over it. The first member may be advanced until itsdistal end also passes through the opening in the body.

In some embodiments, the second member may also be relaxed so that ithas sufficient flexibility that will allow the second member to beguided by the flexible elongated member (that is relatively more rigidthan the relaxed second member), and/or by the first member. In someembodiments, the relaxing of the second member may be accomplished byreleasing tension in wires that are inside the second member, whereinthe wires are configured to bend the second member or to maintain thesecond member in a bent configuration. After the second member isrelaxed, the second member may then be advanced distally relative to theflexible elongated member. The flexible elongated member, while beingflexible, has sufficient rigidity to guide the relaxed second member asthe second member is advanced over it. The second member may be advanceduntil its distal end also passes through the opening in the body. Inother embodiments, instead of advancing the second member after thefirst member, both the first member and the second member may beadvanced simultaneously (e.g., using a drive mechanism) so that theymove together as a unit. In further embodiments, the acts of advancingthe flexible elongated member, the first member, and the second membermay be repeated until a distal end of the flexible elongated member, thefirst member, or the second member has passed through an opening in abody.

In the above embodiments, tension in pull wires in the second elongatedmember is released to make it more flexible than the first elongatedmember, and the second elongated member is then advanced over the firstelongated member while allowing the first elongated member to guide thesecond elongated member. In other embodiments, the tension in the pullwires in the first elongated member may be released to make it moreflexible than the second elongated member. In such cases, the moreflexible first elongated member may then be advanced inside the morerigid second elongated member, thereby allowing the shape of the secondelongated member to guide the advancement of the first elongated member.In either case, the more rigid elongated member may be locked into shapeby maintaining the tension in the pull wires.

In some of the embodiments described herein, the flexible elongatedmember may be a guidewire, wherein the guidewire may have a circularcross section, or any of other cross-sectional shapes. Also, in otherembodiments, the guidewire may have a tubular configuration. In furtherembodiments, the robotic system may further include a mechanism forcontrolling and/or maintaining the preformed configuration of theguidewire. In some embodiments, such mechanism may include one or moresteering wires coupled to a distal end of the guidewire. In otherembodiments, such mechanism may be the catheter 412, the sheath 414, orboth. In particular, one or both of the catheter 412 and the sheath 414may be stiffened (e.g., by applying tension to one or more wires insidethe catheter 412 and/or the sheath 414). The stiffened catheter 412and/or the sheath 414 may then be used to provide support for theguidewire.

Also, in some of the embodiments described herein, any movement of theguidewire, the catheter 412, and/or the sheath 414 may be accomplishedrobotically using a drive assembly. In some embodiments, the driveassembly is configured to receive a control signal from a processor, andactuate one or more driveable elements to move the guidewire, thecatheter 412, and/or the sheath 414.

It should be noted that the driving modes for the system are not limitedto the examples discussed, and that the system may provide other drivingmodes in other embodiments.

V. Clinical Applications

The different driving modes and/or different combinations of drivingmodes are advantageous because they allow a tubular member (catheter412, sheath 414, or combination of both) to access any part of thevasculature. Thus, embodiments of the system described herein may have awide variety of applications. In some embodiments, embodiments of thesystem described herein may be used to treat thoracic aneurysm,thoracoabdominal aortic aneurysm, abdominal aortic aneurysm, isolatedcommon iliac aneurysm, visceral arteries aneurysm, or other types ofaneurysms. In other embodiments, embodiments of the system describedherein may be used to get across any occlusion inside a patient's body.In other embodiments, embodiments of the system described herein may beused to perform contralateral gait cannulation, fenestrated endograftcannulation (e.g., cannulation of an aortic branch), cannulation ofinternal iliac arteries, cannulation of superior mesenteric artery(SMA), cannulation of celiac, and cannulation of any vessel (artery orvein). In further embodiments, embodiments of the system describedherein may be used to perform carotid artery stenting, wherein thetubular member may be controlled to navigate the aortic arch, which mayinvolve complex arch anatomy. In still further embodiments, embodimentsof the system described herein may be used to navigate complex iliacbifurcations.

In addition, in some embodiments, embodiments of the system describedherein may be used to deliver a wide variety of devices within apatient's body, including but not limited to: stent (e.g., placing astent in any part of a vasculature, such as the renal artery), balloon,vaso-occlusive coils, any device that may be delivered over a wire, anultrasound device (e.g., for imaging and/or treatment), a laser, anyenergy delivery devices (e.g., RF electrode(s)), etc. In otherembodiments, embodiments of the system described herein may be used todeliver any substance into a patient's body, including but not limitedto contrast (e.g., for viewing under fluoroscope), drug, medication,blood, etc. In one implementation, after the catheter 412 (leader) isplaced at a desired position inside the patient, the catheter 412 may beremoved, leaving the sheath 414 and guidewire to provide a conduit fordelivery of any device or substance.

In further embodiments, embodiments of the system described herein maybe used to access renal artery for treating hypertension, to treatuterine artery fibroids, atherosclerosis, and any peripheral arterydisease.

In still further embodiments, embodiments of the system described hereinmay be used to access any internal region of a patient that is notconsidered a part of the vasculature. For example, in some cases,embodiments of the system described herein may be used to access anypart of a digestive system, including but not limited to the esophagus,liver, stomach, colon, urinary tract, etc. In other embodiments,embodiments of the system described herein may be used to access anypart of a respiratory system, including but not limited to the bronchus,the lung, etc.

In some embodiments, embodiments of the system described herein may beused to treat a leg that is not getting enough blood. In such cases, thetubular member may access the femoral artery percutaneously, and issteered to the aorta iliac bifurcation, and to the left iliac.Alternatively, the tubular member may be used to access the right iliac.In one implementation, to access the right iliac, the drive assembly maybe mounted to the opposite side of the bed (i.e., opposite from the sidewhere the drive assembly is mounted in FIG. 1). In other embodiments,instead of accessing the inside of the patient through the leg, thesystem may access the inside of the patient through the arm (e.g., foraccessing the heart).

In any of the clinical applications mentioned herein, the telescopicconfiguration of the catheter 412 and the sheath 414 (and optionally theguidewire 482) may be used to get past any curved passage way in thebody, like that similarly discussed with reference to FIGS. 45-48. Forexample, in any of the clinical applications mentioned above, theguidewire 482 may be advanced first, and then followed by the catheter412, and then the sheath 414, in order to advance the catheter 412 andthe sheath 414 distally past a curved (e.g., a tight curved) passageway. In other embodiments, the catheter 412 may be advanced first, andthen followed by the sheath 414, in order to advance the catheter 412and the sheath 414 distally past a curved (e.g., a tight curved) passageway. In still further embodiments, the guidewire 482 may be advancedfirst, and then followed by the catheter 412 the sheath 414 (i.e.,simultaneously), in order to advance the catheter 412 and the sheath 414distally past a curved (e.g., a tight curved) passage way.

VI. Anti-Buckling Feature

FIG. 53A illustrates an implementation of the instrument driver 408 thatincludes the first and second drivable assemblies 182, 184 removeablycoupled to a base. The second drivable assembly 184 is slidable relativeto the first drivable assembly 182. In the illustrated embodiments, thedrivable assembly 184 is configured to control movement of a sheath, andthe drivable assembly 182 is configured to control movement of acatheter member that is inserted into the sheath. During use, thedrivable assembly 184 may be controlled to move the sheath distallytowards the patient, or proximally. Also, the drivable assembly 182 maybe controlled to move the catheter member towards the patient, orproximally. In another mode of operation, the drivable assembly 184 maymaintain the sheath to be stationary while the drivable assembly 182moves the catheter member distally or proximally relative to the sheath.In still another mode of operation, the drivable assembly 182 maymaintain the catheter member to be stationary while the drivableassembly 184 moves the sheath distally or proximally relative to thecatheter member. In another mode of operation, the drivers 182, 184 maycooperate with each other to move the catheter member and the sheathtogether (either distally or proximally), so that the catheter memberwith the sheath can translate as a unit.

As discussed, during an operation, the instrument driver assembly 408may be configured to advance an elongate member (e.g., the sheath, thecatheter member, or combination of both, any of which may be considereda medical device) distally towards the patient. In some embodiments, theelongate member may be constructed to be very flexible. In such cases,to prevent the elongate member from buckling while the elongate memberis advanced towards the patient, an anti-buckling device may be coupledto the instrument driver assembly 408 to support the elongate member.

FIG. 53B illustrates an anti-buckling device 500 a that is configured todetachably couple to the drivable assembly 184 and the drivable assembly182 during use. As shown in FIG. 53B, the anti-buckling device 500 a hasa first end 504 for detachably coupling to the drivable assembly 182,and a second end 506 for detachably coupling to the drivable assembly184. During use, the anti-buckling device 500 a is placed around theelongate member 490 (which may be a catheter member, or another elongatemedical device). The anti-buckling device 500 a is then secured to thedrivable assembly 182 at the first end 504, and to the drivable assembly184 at the second end 506. The anti-buckling device 500 a providessupport along the length of the elongate member 490 between the drivers82, 84, so that as the elongate member 490 is pushed towards the patient(resulting in the elongate member 490 being compressed), the catheterelongate 490 is prevented from buckling.

FIG. 53C illustrates another variation of an anti-buckling device 500 bthat is configured to detachably couple to the drivable assembly 184 anda stabilizer 502 during use. As shown in FIG. 53C, the anti-bucklingdevice 500 b has a first end 504 for detachably coupling to the drivableassembly 184, and a second end 506 for detachably coupling to thestabilizer 502. During use, the stabilizer 502 is attached to apatient's skin, and the anti-buckling device 500 b is placed around theelongate member 490. The elongate member 490 may be a sheath, a cathetermember, a combination of both the sheath and the catheter member, oranother elongate medical device. The distal end of the elongate member490 is then inserted into the patient through the stabilizer 502. Theanti-buckling device 500 b is secured to the drivable assembly 184 atthe first end 504, and to the stabilizer 502 at the second end 506. Theanti-buckling device 500 b provides support along the length of theelongate member 490 between the stabilizer 502 and the drivable assembly184, so that as the elongate member 490 is pushed towards the patient(resulting in the elongate member 490 being compressed), the elongatemember 490 is prevented from buckling.

FIGS. 53D and 53E illustrate the anti-buckling device 500 a in furtherdetail. The anti-buckling device 500 a includes a first coupler 508 atthe first end 504, a second coupler 509 at the second end 506, and aplurality of support members 510, 512, 514 coupled between the couplers508, 509. The first coupler 508 has a slot 530 configured (e.g., shapedand/or sized) to detachably mate with an anchor element 532 at thedrivable assembly 182 (FIG. 53H). The second coupler 509 has a slot 534for receiving a protrusion 537 at the drivable assembly 184, and anopening 536 for receiving a shaft 538 at the drivable assembly 184 (FIG.53I). The second coupler 509 may be detachably coupled to the drivableassembly 184 by placing the second coupler 509 over the shaft 538, whileallowing the protrusion 537 to pass the initial entry point at thecoupler 509. The coupler 509 is then rotated to lock the protrusion 537within the slot 534. In other embodiments, the coupler 509 may havedifferent configurations. For example, in other embodiments, the coupler509 may include an active valve connector hub that is configured todetachably couple to an active valve release hub (FIG. 53M). Thisconfiguration allows a user to connect the connector hub to the activevalve, and rotate it in order to open or close the active valve asdesired.

Returning to FIG. 53D, the support members 510 are on one side of theanti-buckling device 500 a, the support members 512 are on the oppositeside of the anti-buckling device 500 a, and the support members 514 arelocated in the middle between the first and second sets of supportmembers 510, 512. In the illustrated embodiments, support members 510 m512 create the scissor mechanism. The support members 514 create anadditional set of linkages that is offset from the support members 510,512. The purpose of the support members 514 is to hold the eyelets 540in line. The elongate member held between two eyelets 540 will have muchgreater buckling resistance if the eyelets 540 are prevented from beingrotated. In other embodiments, the number of support members 510, 512,514 may be different from that shown in the figure. In particular, onone side of the anti-buckling device 500 a, the support members 510 a,510 b are rotatably coupled to the coupler 509 via joint 524, andsupport members 510 u, 510 v are rotatably coupled to the coupler 508via joint 526. The rest of the support members 510 c-510 t are coupledtogether via joints 528 between the first and second ends 504, 506 in ascissor-like configuration. In other embodiments, the support members514 are optional, and the anti-buckling device does not include thesupport members 514.

As shown in FIG. 53E, on the other side of the anti-buckling device 500a, the support members 512 a, 512 b are rotatably coupled to the coupler509 via joint 524, and support members 512 u, 512 v are rotatablycoupled to the coupler 508 via joint 526. The rest of the supportmembers 512 c-512 t are coupled together via joints 528 between thefirst and second ends 504, 506 in a scissor-like configuration.

It should be noted that providing two sets of support members 510, 512are advantageous in that they collectively provide sufficient stiffnessfor the anti-buckling device 500 a in the Y-direction so that theanti-buckling device 500 a will not sag or deflect significantly in theY-direction between the supports at ends 506, 506. In other embodiments,the support members 510 may be made sufficiently stiff, and the jointscoupling the various components of the anti-buckling device 500 a may beconfigured to have a tight tolerance. In such cases, the anti-bucklingdevice 500 a may not require the second set of support members 512.

In the illustrated embodiments, the anti-buckling device 500 a alsoincludes a plurality of connectors 516 that connects the support members510, 512, 514. Each connector 516 includes a first joint 518 forrotatably coupling to two of the support members 510, a second joint 520for rotatably coupling to two of the support members 512, and a thirdjoint 522 for rotatably coupling to two of the support members 514.

As shown in FIG. 53K, the anti-buckling device 500 a also includes aplurality of holders 540 coupled between the first and second sets ofsupport members 510, 512 at the respective joints 528. Each holder 540has an opening 542 for accommodating the elongate member 490, a firstjoint 544 for rotatably coupling to one of the support members 514, anda second joint 546 for rotatably coupling to another one of the supportmembers 514. The support members 514 together with the holders 540 areconfigured to support the elongate member 490 as the elongate member 490is being inserted into the patient. In particular, as the anti-bucklingdevice 500 a is being extended (FIG. 52L) (e.g., by moving the ends 504,506 further away from each other) or collapsed (FIG. 53D)(e.g., bymoving the ends 504, 506 closer towards each other), the support members514 are configured to move the holders 540 along the longitudinal axisof the elongate member 490 relative to the elongate member 490 so thatthe holders 540 are spaced substantially evenly or equally along theaxis of the elongate member 490. In some embodiments, the holders 540are considered to be spaced substantially evenly or equally when theirspacing does not vary by more than 20%. The support members 514 alsomaintain all of the holders 540 in the same orientation relative to eachother as the anti-buckling device 500 a is being extended or collapsed.

In one or more of the embodiments described herein, the support members510 (or members 512, or members 14) at one end (e.g., end 504 or 506) ofthe anti-buckling device 500 may optionally have mating gears (FIG.53J). This ensures that the support members 510/512/514 on either sideof the longitudinal axis 541 along the length of the anti-bucklingdevice 500 will rotate by the same amount relative to the axis 541. Thisfeature is also advantageous because it ensures that the holders 540will be oriented so that the axis of the opening 542 for each of theholders 540 is substantially parallel to the longitudinal axis 541 ofthe anti-buckling device 500.

As shown in the illustrated embodiments, the anti-buckling device 500 aprovides a plurality of supports at the locations of the holders 540that are evenly spaced along the length of the elongate member 490regardless of how much the elongate member 490 is inserted into thepatient (i.e., regardless of the distance between the first and secondends 504, 506). The plurality of supports shortens the buckling lengthof the elongate member 490, thereby significantly improving the bucklingstrength of the elongate member 490. It should be noted that theplurality of supports will prevent the elongate member 490 from bucklingin a direction within the X-Z plane because the anti-buckling device 500a is very stiff in X-Z plane. Also, since the anti-buckling device 500 ais relatively stiffer than the elongate member 490 in the Y-direction,the anti-buckling device 500 a will also provide supports for thecatheter member in all directions within the Y-Z plane to prevent theelongate member 490 from buckling in a direction that is within the Y-Zplane.

In other embodiments, to increase the rigidity of the anti-bucklingdevice, the support members 510, 512, 514 may be implemented using acombination of a composite beam and a plastic beam (FIG. 53L). As shownin FIG. 53L, the composite beam may be formed from two stainless steelmembers that are spaced apart from each other with two stainless steelspacers therebetween. The plastic beam may be a PEEK beam. The compositebeam and the plastic beam may be linked together to the connector 516 atone end via a hinge (e.g., rivet(s)).

The anti-buckling device 500 a may be made from a variety of differentmaterials. For example, in some embodiments, the support members 510,512, 514 may be made from metal, alloys, plastics, polymers, etc. Also,in some embodiments, the connectors 516, and the couplers 508, 509 maybe made from metal, alloys, plastics, polymers, etc. In addition, in oneor more of the embodiments described herein, any moving parts in theanti-buckling device that contact each other may be made from the samematerial (e.g., stainless steel), or different materials (e.g.,stainless steel for one, and PEEK for the other). Making two contactingparts that interact with each other with different respective materialsis advantageous because it may allow the moving parts to move relativelyto each other more easily without seizing. Furthermore, in one or moreof the embodiments described herein, one or more components (e.g.,support members 510, 512, 514) of the anti-buckling device may be madefrom a light weight material, such as PEEK (plastic), to reduce theoverall weight of the anti-buckling device. Also, in one or more of theembodiments described herein, any of the joints (e.g., joints 520,joints 522, or joints 528) may be implemented using pins (e.g., dowelpins), rivets, or combination thereof. In one implementation, thesupport members 510, 512, 514 may be made from stainless steel and/orPEEK, the holders 540 may be made from PEEK, the rivets/pins may be madefrom stainless steel, the component housing the rivets/pins may be madefrom PEEK, and the end couplers 508, 509 (and similarly, couplers 550,552 in the second anti-buckling device 500 b shown in FIG. 53F) may bemade from PEEK/Ultem.

The second anti-buckling device 500 b is illustrated in further detailin FIG. 53F. The anti-buckling device 500 b has the same configurationas the anti-buckling device 500 a, except that it is used to preventbuckling between the drive assembly 184 and the insertion site or thepatient. This insertion site may be at the left or right femoral arteryor alternatively may be the left or right brachial artery, etc. Itsproximal end 504 has a first coupler 550 for detachably coupling to thedrivable assembly 184, and its distal end 506 has a second coupler 552for detachably coupling to the stabilizer 502 (FIG. 53C). The firstcoupler 550 of the anti-buckling device 500 b has the same configurationas the second coupler 509 of the anti-buckling device 500 a, and isconfigured to detachably couple to a connector at the drivable assembly184 (FIG. 53G). As shown in FIG. 53G, the second coupler 552 has anopening 554 for allowing the elongate member 490 to extend therethrough.The second coupler 552 also has a pair of protrusions 556 for insertinginto a slot at the stabilizer 502, and a wall 558 for allowing thestabilizer 502 to anchor thereto. The second coupler 552 may also bedirectly connected to the introducer sheath at the insertion site.

Refer now to FIG. 54, the stabilizer 502 will now be described infurther detail. The stabilizer 502 includes a base 560 with adhesive atits bottom side for attachment to a patient's skin, and a connector 562for coupling with the coupler 552 of the anti-buckling device 500 b.Alternatively, the base 560 or the coupler 552 may be attached to a bedor other support during use. In some embodiments, the base 560 may be aHDPE platform that includes a strain relief material underneath forproviding transition from the rigid HDPE material to the patient skin.The base 560 may also include a butterfly peel-away liner (e.g.,tear-resistant HDPE liner) that covers the adhesive material at thebottom side of the platform. During use, the liner may be peeled away toexpose the adhesive at the bottom side of the base 560. The stabilizer502 also includes an opening 564 formed at the base 560 for allowing theelongate member 490 to reach the patient's skin. The interface mechanism564 includes a pair of slots 566 for receiving the respectiveprotrusions 556 at the coupler 552, and a pair of moveable anchors 568for anchoring against the wall 558 of the coupler 552.

FIGS. 55A and 55B illustrate the stabilizer 502 in exploded view,particularly showing the components of the stabilizer 502. The connector562 includes a bottom piece 570 with the two slots 562, a top piece 572,and two rotatable anchoring components 574, 576 located between thebottom piece 570 and the top piece 572. A screw 580 is provided forextending through the top piece 572, and the anchoring components 574,576, to reach screw opening 578 at the bottom piece 572, therebycoupling the various components together. The connector 562 alsoincludes a spring 582 (in the form of an elastic plate, e.g., formedusing a metal, alloy, or plastic) for biasing the anchoring components574, 576 so that their respective anchors 568 are urged towards eachother. During use, when the coupler 552 is inserted into the slots 566,the insertion force will push wall 558 of the coupler 552 towards theanchors 568, thereby spreading the anchors 568. When the coupler 552 isfurther inserted into the slots 566, the wall 558 will pass the anchors568, thereby allowing the anchors 568 to close towards each other due tothe biasing force provided by the spring element 582. The anchoringcomponents 574, 576 also include respective levers 584, 586 for allowinga user to move the anchors 568 away from each other. In particular, whenthe levers 584, 586 are pressed towards each other, they bend the spring582 against the curvilinear support 588 at the bottom piece 570, therebyovercoming the biasing force that was urging the anchors 568 towardseach other. This allows a user to remove the coupler 552 from theconnector 562 at the stabilizer 502.

As shown in FIG. 55C, in some embodiments, the system may furtherinclude a lubricating system 680 coupled to the stabilizer 502. Thelubricating system 680 is configured to apply fluid (e.g., saline, gel)onto the exterior surface of the catheter 412 as the catheter 412 isbeing advanced through the lubricating system 680. As shown in FIGS.55D-55F, the lubricating system 680 includes a base 684 and a cover 682coupled to the base 684 via a joint 686. The hinge 686 allows the cover682 to be rotated relative to the base 684, so that the system is alwaysin contact with the catheter irrespective of the angle of entry of thecatheter into the patient. As shown in FIG. 55F, the lubricating system680 also includes a slot 688 formed at the base 684, which is configuredto mate with the ring structure formed around the opening 554 at thecoupler 552 (FIG. 53G). The lubricating system 680 also includes anabsorbent material 690 underneath the cover 682, wherein the material690 has a slot or cut-portion 692 for applying fluid to the catheter412. During use, the catheter 412 exiting from the opening 554 at thecoupler 552 will go through the slot or cut-portion 692, therebycontacting the absorbent material 690. The absorbent material 690 willbe sterile and will be soaked with saline by the user at the start ofthe procedure and then it automatically applies the fluid onto thesurface of the catheter 412 as it passes therethrough. In someembodiments, the catheter 412 may be coated with a hydrophilic coatingto reduce friction as they are pushed through the anatomy. In suchcases, the lubricating system 680 may be used to hydrate the hydrophiliccoating to activate it. As illustrated in the above embodiments, thelubricating system 680 provides a self lubricating or self hydrationmechanism for robotically controlled catheter. This is advantageousbecause the doctor who is controlling the catheter remotely would beunable to manually wet the catheter with a wet gauze.

It should be noted that the anti-buckling device 500 is not limited tothe above configuration, and that the anti-buckling device 500 may haveother configurations in other embodiments. For example, in otherembodiments, instead of having three sets of supports 510, 512, 514, theanti-buckling device 500 may include only two sets of supports. FIG. 56illustrates another anti-buckling device 500 in accordance with otherembodiments. The anti-buckling device 500 is similar to the embodimentsof FIGS. 52 and 53, except that it has one set of support members 510 onone side of the anti-buckling device 500, and another set of supportmembers 514 next to the first set of support members 510 for maintainingthe holders 540 in the same orientation relative to each other. In theembodiment of FIG. 56, the anti-buckling device 500 does not include theset of support members 512 like that shown in FIG. 52. Also, unlike theembodiments of FIGS. 52 and 53, the embodiment of FIG. 56 includessupport members 514 only on one side, wherein the support members 514are coupled to the respective joints 544 on only one side of the holders540. In other embodiments, additional support members 514 may beprovided on the opposite sides, in which case, the support members 514will be coupled to the respective joints 546 at the holders 540. Theanti-buckling device 500 shown in FIG. 56 may have different connectors(not shown) at opposite ends, such as those shown in FIGS. 52 and 53,for detachably coupling to different medical devices/components.

As shown in FIG. 56, the support members 512 are relatively thicker thanthose in FIGS. 52 and 53. Such configuration provides sufficientstiffness for the anti-buckling device 500 in the Y-direction whileobviating the need for the third set of support members 512, so that theanti-buckling device 500 will not sag or deflect significantly.

In the embodiment of FIG. 56, the support members 514 together with theholders 540 are configured to support the elongate member 490 as theelongate member 490 is being inserted into the patient. In particular,as the anti-buckling device 500 is being extended (e.g., by moving theends 504, 506 further away from each other) or collapsed (e.g., bymoving the ends 504, 506 closer towards each other), the support members514 are configured to move the holders 540 along the longitudinal axisof the elongate member 490 so that the holders 540 are spaced evenlyalong the axis of the elongate member 490. The support members 514 alsomaintain all of the holders 540 in the same orientation relative to eachother as the anti-buckling device 500 is being extended or collapsed.

As shown in the illustrated embodiments, the anti-buckling device 500provides a plurality of supports at the locations of the holders 540that are evenly spaced along the length of the catheter member 90regardless of how much the elongate member 490 is inserted into thepatient (i.e., regardless of the distance between the first and secondends 504, 506). The plurality of supports shortens the buckling lengthof the elongate member 490, thereby significantly improving the bucklingstrength of the elongate member 490. It should be noted that theplurality of supports will prevent the elongate member 490 from bucklingin a direction within the X-Z plane because the anti-buckling device 500is very stiff in X-Z plane. Also, since the anti-buckling device 500 isrelatively stiffer than the elongate member 490 in the Y-direction, theanti-buckling device 500 will also provide supports for the elongatemember 490 in the Y-direction to prevent the catheter member 90 frombuckling in a direction that is within the Y-Z plane.

In any of the anti-buckling devices described herein, the buckleresistance increases as the unsupported length of the catheter getsshorter. The length of the catheter outside the patient gets shorter asthe catheter is advanced further into the patient. Thus, as the catheteris being advanced into the patient, the unsupported length of thecatheter becomes shorter, resulting in a higher buckling resistanceprovided to the catheter by the anti-buckling device. Therefore, theanti-buckling device provides a variable stiffness that allows thecatheter's buckling capacity to increase as the catheter is beingadvanced into the patient. The further the catheter is advanced into thepatient, the higher the insertion force is required to advance thecatheter. In some embodiments, the buckle force of the anti-bucklingdevice is always higher than the catheter insertion force.

In one or more of the embodiments of the anti-buckling device 500described herein, the anti-buckling device 500 should not be limited tothe planar configuration, and the anti-buckling device 500 may have anon-planar configuration. For example, as shown in FIG. 57, theanti-buckling device 500 may have a non-planar configuration that isformed by orienting the support members 510 and the support members 514in respective truss-configurations. FIG. 57 shows the anti-bucklingdevice 500 in an extended configuration, and FIG. 58 shows theanti-buckling device 500 in a collapsed configuration. FIG. 59 shows across section of the anti-buckling device 500, particularly showing thesupport members 510 forming a truss configuration, and the supportmembers 514 forming another truss configuration. In particular, eachsupport member 510 forms an angle 590 relative to the X-Z plane, andeach support member 514 forms an angle 592 relative to the X-Z plane. Inthe illustrated embodiments, the anti-buckling device 500 does notinclude the second set of support members 512. However, in otherembodiments, the anti-buckling device 500 may optionally further includethe second set of support members 512. In such cases, the supportmembers 512 will be coupled to the joints 528 at the holders 540.

As shown in the illustrated embodiments of FIG. 57-59, the anti-bucklingdevice 500 provides a plurality of supports at the locations of theholders 540 that are evenly spaced along the length of the elongatemember 490 regardless of how much the elongate member 490 is insertedinto the patient (i.e., regardless of the distance between the first andsecond ends 504, 506). The plurality of supports shortens the bucklinglength of the elongate member 490, thereby significantly improving thebuckling strength of the elongate member 490. It should be noted thatthe plurality of supports will prevent the elongate member 490 frombuckling in a direction within the X-Z plane because the anti-bucklingdevice 500 is very stiff in X-Z plane. Also, due to the trussconfigurations of the support members 510, 514, the anti-buckling device500 is also very stiff in the Y-direction. Thus, the anti-bucklingdevice 500 will also provide supports for the elongate member 490 in theY-direction to prevent the elongate member 490 from buckling in adirection that is within the Y-Z plane.

The anti-buckling device 500 shown in FIG. 57 may have differentconnectors (not shown) at opposite ends, such as those shown in FIGS. 52and 53, for detachably coupling to different medical devices/components.

FIG. 60 illustrates another anti-buckling device 500 in accordance withother embodiments. The anti-buckling device 500 is similar to theembodiment shown in FIG. 57, except that each support members 510 has adifferent shape, and that the anti-buckling device 500 also includesadditional support members 512 on the opposite sides. Also, the supportmembers 514 in the anti-buckling device 500 of FIG. 60 are in the formof tension wires. During use, the support members 514 keep the holders542 all aligned in the same orientation relative to each other.

In one or more of the embodiments described herein, the anti-bucklingdevice 500 may not include the set of support members 514 that link theholders 540 together. FIG. 61A illustrates a variation of theanti-buckling device 500 that does not include any linkage members 514for the holders 540. In the illustrated embodiments, the holders 540 arefree to rotate relative to each other. In such cases, the elongatemember 490 may be made to have a sufficient bending stiffness so thatthe bending stiffness of the elongate member 490 will prevent eachholder 540 from rotating too much relative to the longitudinal axis ofthe anti-buckling device 500. In such cases, while the stiffness of theelongate member 490 is sufficient to rotatably guide the holders 540, itmay be insufficient to prevent buckling of the elongate member 490(i.e., in the situation in which there is no anti-buckling mechanism).During use, the anti-buckling device 500 may have an extendedconfiguration, like that shown in FIGS. 61A and 61C, or a collapsedconfiguration, like that shown in FIGS. 61B and 61D.

FIG. 62 illustrates another variation of the anti-buckling device 500 inaccordance with other embodiments. The anti-buckling device 500 includesa plurality of support members 600. Although only two support members600 are shown, in other embodiments, the anti-buckling device 500 mayinclude more than two support members 600. Each support member 600 has afirst portion 602 and a second portion 604 that are secured to eachother at their respective ends. The first portion 602 has an opening 606that is aligned with an opening 608 at the second portion 604. Theopenings 606, 608 allow the elongate member 490 to extend therethroughduring use. Each of the first and second portions 602, 604 has acurvilinear profile. In one implementation, each of the portions 602,604 may be formed by bending a plate to a desired profile, and thensecuring them relative to each other at their respective ends. In otherembodiments, each of the portions 602, 604 may not have a curvilinearprofile, and may instead have a rectilinear profile (e.g., a U or Cshape with straight portions).

In the illustrated embodiments, each of the support members 600 iselastic, and can be deformed during use. In particular, the portions602, 604 may be bent to vary the distance between the openings 606, 608.For example, during use, the drivable assembly 184 may be moved towardsthe stabilizer 502 to move the elongate member 490 distally.Accordingly, the anti-buckling device 500 of FIG. 62, which is placedaround the elongate member 490 during use, is compressed. Thecompression of the anti-buckling device 500 causes the portions 602, 604to bend towards each other, thereby shortening the unsupported length ofthe elongate member 490 between the supports at the respective openings606, 608.

The configuration of the anti-buckling device 500 of FIG. 62 isadvantageous in that it has significantly fewer components (compared tothe embodiments of FIGS. 52 and 53). Also, the anti-buckling device 500of FIG. 62 does not require separate holders and associated linkage formaintaining the holders in the same orientation. Instead, the openings606, 608 at the portions 602, 604 of each support member 600 will bealigned in the same orientation as the anti-buckling device 500 isextended or collapsed. Furthermore, because each of the openings 606,608 circumscribes completely around the elongate member 490 during use,each of the portions 602, 604 provides support against the elongatemember 490 to prevent the elongate member 490 from buckling in anyradial direction during use.

In other embodiments, the support members 600 do not need to be orientedin the same direction. Instead, a first set of every other supportmembers 600 may be orientated in a first direction, and a second set ofevery other support members 600 may be oriented in a second directionthat is perpendicular to the first direction (FIG. 63).

FIG. 64A illustrates another anti-buckling device 500 in accordance withother embodiments. The anti-buckling device 500 has a first portion 620and a second portion 622 that can be detachably coupled to the firstportion 620 in a zipper-like manner along the length of the elongatemember 490 during use. As shown in FIG. 64B, the first portion 620 andthe second portion 622 have respective C-shape cross sections, andcollectively define a space 624 for housing the elongate member 490during use. In other embodiments, each of the first portion 620 and thesecond portion 622 does not need to have a C-shape cross section, andmay have other cross sectional shapes as long as they provide supportfor the elongate member 490 to prevent it from buckling. 620 and 622 donot necessarily need to have C-shaped cross sections, and may have othercross-sectional shapes in other embodiments. The design can be adjustedto add bending stiffness as shown in FIG. 64C or 64D.

During use, the portions 620, 622 of the anti-buckling device 500 isplaced around the elongate member 490 (FIG. 64A). The distal end of theanti-buckling device 500 is then secured to the stabilizer 502 (e.g.,using coupler 522 or another securing mechanism). The anti-bucklingdevice 500 may further include supports 626, 628 that are proximalrelative to the distal end of the anti-buckling device 500. The supports626, 628 are configured to hold the portions 620, 622, respectively, asthey are un-zipped. The drivable assembly 184 may be advanced towardsthe stabilizer 502 to push the elongate member 490 distally, therebyshortening the length between the stabilizer 502 and the drivableassembly 184. When this occurs, parts of the portions 620, 622 at theirproximal ends unzip and translate through the supports 626, 628.Alternatively, the drivable assembly 184 may be retracted proximally tomove away from the stabilizer 502, thereby increasing the length betweenthe stabilizer 502 and the drivable assembly 184. Accordingly, parts ofthe portions 602, 622 will come together and zip against each other inincrease the support portion for the elongate member 490. Thus, theamount of anti-buckling support provided by the anti-buckling device 500for the elongate member 490 automatically increases in response to anincrease in the unsupported length of the elongate member 490, andautomatically decreases in response to a decrease in the unsupportedlength of the elongate member 490.

In other embodiments, the anti-buckling device 500 of FIG. 64A may beused to support other parts of the elongate member 490. For example, inother embodiments, the anti-buckling device 500 may provideanti-buckling support for the elongate member 490 that spans between thedrivable assembly 182 and the drivable assembly 184 (FIG. 53A).

FIG. 65A illustrates another anti-buckling device 500 in accordance withother embodiments. The anti-buckling device 500 includes a plurality oftubes 640 that are arranged in a telescopic configuration. The tubes 640may have a circular cross section, or other cross sectional shapes inother embodiments. During use, the telescopic tubes 640 are placedaround the elongate member 490. As the drivable assembly 184 is advanceddistally, the tubes 640 retracts relative to each other to form ashorten configuration. As the driver is moved proximally, the tubes 640extends out of their respective neighboring tubes 640 to form a lengthenconfiguration. The elongate member 490 is housed within the lumen formedcollectively by the tubes 640, and is prevented from buckling by thewall of the tubes 640. It should be noted that at the larger tubes 640location, the elongate member 490 may not initially be in contact withthe wall of the tubes 640. However, as the elongate member 490 is beingcompressed, the elongate member 490 will bend slightly due to the axialcompression force applied on the elongate member 490. The bending of theelongate member 490 will bring the elongate member 490 into contact withthe wall of the relatively larger tubes 640. When this happens, thetubes 640 will prevent the elongate member 490 from bending further, andwill prevent the elongate member 490 from catastrophic buckling.

FIGS. 65D-65G illustrates an implementation of the anti-buckling device500 of FIG. 65A in accordance with some embodiments. As shown in FIGS.65F and 65G, each tube 640 has a stopper 641 at one end, and anotherstopper 642 at the opposite end. The stoppers 641, 642 are configured tocouple the tubes 640 together, and prevent the tubes 640 from beingdetached from each other.

FIG. 65B illustrates a variation of the anti-buckling device 500 of FIG.65A, particularly showing the tubes 640 being arranged from the smallestsize to the largest size in the proximal-to-distal direction.

FIG. 65C illustrates another variation of the anti-buckling device 500of FIG. 65A, particular showing the tubes 640 being arranged from thelargest size at one end to the smallest size in the middle section, andthen to the largest size again to another end.

In the above embodiments, the anti-buckling device 500 may be providedon a robotic catheter when the drive assembly for the catheter is at theproximal end of the catheter. However, in other embodiments, the drivesystem may be provided at the distal end of the catheter for “pulling”the flexible catheter rather than “pushing” it. FIG. 66A illustrates adrive device 500 that provides an anti-buckling feature in accordancewith other embodiments. The device 500 includes a pair of rollers 660that grip against the elongate member 490 at a distal location that isclose to the incision site. The device 500 also includes mechanicallinkage 662 connecting the rollers 660 to the drivable assembly 184.During use, the drivable assembly 184 may be advanced distally to movethe elongate member 490 into the incision site. When this occurs, thedrivable assembly 184 will actuate the rollers 660 to apply tension tothe elongate member 490. This will prevent the elongate member 490 frombeing compressed (or from being compressed excessively), and prevent theelongate member 490 from buckling.

FIG. 66B illustrates another drive device 500 that provides ananti-buckling feature in accordance with other embodiments. The device500 includes a first pair of fingers 670 a for gripping against theelongate member 490 at a distal location that is close to the incisionsite. The device 500 also includes a second pair of fingers 670 b forgripping against the elongate member 490 at a distal location that isclose to the incision site. The system 500 also includes mechanicallinkage 672 connecting the first and second pair of fingers 670 a, 670 bto the drivable assembly 184. During use, the drivable assembly 184 maybe advanced distally to move the elongate member 490 into the incisionsite. When this occurs, the drivable assembly 184 will alternatelyactuate the first and second pairs of fingers 670 a, 670 b in accordanceto a predetermined algorithm to apply tension to the elongate member490. This will prevent the elongate member 490 from being compressed (orfrom being compressed excessively), and prevent the elongate member 490from buckling.

In some embodiments, the algorithm for controlling the pairs of fingers670 a, 670 b may be as follows: (1) Actuate first pair to grip theelongate member 490, (2) translate the first pair along the longitudinalaxis of the elongate member 490 to pull the elongate member 490, (3)actuate the second pair to grip the elongate member 490, (4) release thefirst pair, (5) translate the second pair along the longitudinal axis ofthe elongate member 490 to pull the elongate member 490, (6) move backthe first pair by some distance, (7) actuate the first pair to grip theelongate member 490, (8) translate the first pair along the longitudinalaxis of the elongate member 490 to pull the elongate member 490, (9)move back the second pair by some distance, and repeat (3)-(9) to movethe elongate member 490 until the elongate member 490 is desirablepositioned.

FIGS. 67A-67C illustrate another anti-buckling device 500 in accordancewith other embodiments. The device 500 includes support members 510 thatform into a scissor-like configuration. The device 500 may optionallyinclude another set of support members 512 next to the support members510, as similarly described previously. The device 500 includes aplurality of holders 540 that are coupled to the support members 510,wherein each holder 540 includes an opening for accommodating anelongated member 490 (e.g., a sheath, catheter, etc.). As shown in thefigure, the device 500 further includes another set of support members514. As illustrated in FIGS. 67B-67C, the support members 510, 514,holder 540, and coupler 516 form a parallelogram, which allows theholder 540 and coupler 516 to be maintained parallel relative to eachother as the support members 510, 514 rotate. Since all of the holders540 are maintained in parallel relative to their respective adjacentcouplers 516, all of the holders 540 are also maintained in parallelrelative to each other as the support members 510, 514 rotate tocollapse or extend the device 500. The above configuration isadvantageous because by preventing the holders 540 from rotatingrelative to each other, the device 500 provides a higher anti-bucklingresistance for the elongated member 490 (i.e., it will be harder tobuckle the elongated member 490). This is because when the holders 540stay aligned relative to each other, the buckling load of the elongatedmember 490 is 4π²EI/L². On the other hand, when the holders 540 areallowed to freely rotate relative to each other, the buckling load ofthe elongated member 490 is π²EI/L². Therefore, the elongated member 490can undergo four times as much compressive force when the holders 540are rotatably constrained than when the holders 540 are freely rotatablerelative to each other.

As shown in the above embodiments, the device 500 is advantageousbecause it shortens the unsupported length of the elongate member 490,thereby preventing the elongate member 490 from buckling during use. Thedevice 500 is also advantageous because it provides anti-bucklingfeature from outside the elongate member 490, and thus, obviating theneed to modify the construction of the elongate member 490. Also,embodiments of the device 500 described herein provide support(s) alongthe length of the elongate member 490 in all circumferential directionsat the location of the support(s). This has the benefit of preventingthe elongate member 490 from buckling in any direction during use.

Although embodiments of the anti-buckling/drive device 500 have beendescribed with reference to the device 500 being used at certainlocation of the robotic system, in other embodiments, one or more of theembodiments of the device 500 may be used to support any flexibleelongate member anywhere in the robotic system, including the flexibleelongate member between the stabilizer 502 and the drivable assembly184, the flexible elongate member between the drivable assembly 184 andthe drivable assembly 182, or any other member that needs support toprevent the member from buckling.

Also, although embodiments of the anti-buckling device 500 have beendescribed with reference to a medical robotic system, it should be notedthat the anti-buckling device 500 described herein may be used toprovide anti-buckling feature for any medical device having an elongateand flexible configuration. For example, in other embodiments,embodiments of the anti-buckling device 500 described herein may be usedto support any flexible tool in the field of medicine, such as anendoscope, a flexible grasper, laser fibers, etc.

Also, one or more of the embodiments of the anti-buckling device 500described herein may be used as a distance measurement tool. Forexample, in some embodiments, a pull string attached to a spring and anencoder may be used to track the displacement of the anti-bucklingdevice 500. In other embodiments, an encoder may be attached to any ofthe joints at the anti-buckling device 500 to measure the angle of alink (or links), and a processor may then calculate the overall lengthof the anti-buckling device 500 based on the measured angle. In otherembodiments, an optical device may be configured to take an image of atleast a portion of the anti-buckling device 500 (or the entireanti-buckling device 500), and the length of the anti-buckling device500 may then be determined (e.g., by a processor) using the image. Instill further embodiments, a short stroke LVDT or similar linear encodermay be used to measure a displacement between any two links, and theprocessor may then calculate the overall length of the anti-bucklingdevice 500 using the measured displacement. In further embodiments, anultrasound transducer may be used to measure a relative displacementbetween two links, and the processor may then calculate the overalllength of the anti-buckling device 500 using the measured displacement.

In addition, in one or more of the embodiments of the anti-bucklingdevice 500, the device 500 may further include a motor coupled to anyone of the joints. In such cases, the motor may be activated to turn thejoint, thereby extending or collapsing the anti-buckling device 500. Inother embodiments, a linear motor may be coupled between two joints orbetween two support members. In such cases, the linear motor may beoperated to extend or collapse the anti-buckling device 500. Forexample, in other embodiments, any of the joints 528 may be fixedrelative to a global system. In such cases, the proximal end of theanti-buckling device 500 may be actuated (e.g., by linearly translatinga support member 510/512/514, or by rotating a joint that couples to anend of a support member 510/512/514). In response to such actuation, thedistal end of the anti-buckling device 500 will translate distally. Theamount of distal translation by the distal end of the anti-bucklingdevice 500 will depend on which of the joints 528 is fixed. Fixing ajoint 582 that is closer to the proximal end would allow the distal endof the anti-buckling device 500 to move a relatively greater distance inresponse to a small translation of the proximal end of the anti-bucklingdevice 500, but such configuration may require a relatively largeractuating force to be applied at the proximal end (and the forcetransmitted to the distal end is relatively small compared to the forceapplied at the proximal end). On the other hand, fixing a joint 582 thatis closer to the distal end would allow the distal end of theanti-buckling device 500 to move a relatively small distance in responseto a large translation of the proximal end of the anti-buckling device500, but such configuration may require a relatively small actuatingforce to be applied at the proximal end (and the force transmitted tothe distal end is relatively large compared to the force applied at theproximal end). In one or more of the embodiments described herein, theelongate member 490 may be coupled to the anti-buckling device 500, theanti-buckling device 500 may be used to move the elongate member 490proximally and distally. For example, in some embodiments, the distalend of the elongate member 490 may be coupled to the distal end of theanti-buckling device 500.

As illustrated in the above embodiments, the anti-buckling deviceutilizes a scissor-like mechanism that provides a 1:1 motion for theelongate member 490. That means when the proximal end of the member 490is advanced distally by a distance, the distal end of the member 490will be advanced by the same distance. Also, when the proximal end ofthe member 490 is retracted proximally by a distance, the distal end ofthe member 490 will be retracted by the same distance. This isadvantageous over a system that does not have any anti-bucklingmechanism, in which case, advancement of the proximal end of theelongate member by a distance may not result in advancement of thedistal end of the elongate member by the same distance (because theelongate member may sag or buckle). Also, due to sagging or buckling,retraction of the proximal end of the elongate member by a distance mayalso not result in retraction of the distal end of the elongate memberby the same distance (because the sagged or buckled section needs to bestraighten out before the distal end of the elongate member may bepulled proximally). Accordingly, embodiments of the anti-bucklingmechanism described herein provides a support frame that has nohysteresis between insert and withdrawal of the elongate member.

Also, in some embodiments, the compressed length of the anti-bucklingdevice may be at least 5 times shorter than its extended length. Inother embodiments, the ratio between the compressed length and theextended length may have any values.

Also, as illustrated in the above embodiments, the anti-buckling deviceprovides high lateral stiffness to support an elongate member laterally,while providing a low axis stiffness so that the anti-buckling devicemay be compressed in response to a decrease in length of the elongatemember as the elongate member is being advanced distally. Thus, theanti-buckling device does not deflect laterally (e.g., in one plane, orin two planes that form an angle relative to each other), and can becompressed in response to axial force.

VII. Lubrication Mechanism

In one or more of the embodiments described herein, the anti-bucklingdevice 500 may further include a lubrication system for lubricating atleast a portion of the elongate member 490. FIG. 68 illustrates alubricating system 700 attached to one end (e.g., the distal end) of theanti-buckling device 500. The lubricating system 700 includes acontainer 702 for housing fluid, such as saline, and an absorptionmaterial 704 located in the housing for absorbing the fluid and applyingthe fluid to the elongate member 490. The container 702 is coupled tothe anti-buckling device 500 via a coupler 710. The lubricating system700 also includes an introducer for allowing the elongate member 490 tobe inserted therethrough. In the illustrated embodiments, the coupler710 has an opening for allowing the elongate member 490 to extendtherethrough. The elongate member 490, which may be a sheath, a cathetermember, or a combination of both. In some embodiments, the elongatemember 490 may optionally include a hydrophilic coating so that theelongate member 490 may interact (e.g., dissolve) with the saline. Thedissolved coating becomes a lubricant for lubricating the elongatemember 490 (which may allow the elongate member 490 to slide easilyrelative to object(s) that it comes in contact with—e.g., bodily tissue,supports of anti-buckling device, etc.). In other embodiments, thesterile fluid in the container 702 may itself be the lubricant, in whichcase, the lubricant is applied directly onto the elongate member 490 bythe absorption material 704. During use, fluid (e.g., saline) is placedin the container 702, or may be applied directly to the absorptionmaterial 704. The elongate member 490 is then inserted through theanti-buckling device 500, and is advanced through the absorptionmaterial 704 that is located in the container 702. As the elongatemember 490 is advanced through the absorption material 704, theabsorption material 704 applies the fluid onto the surface of theelongate member 490, thereby lubricating the elongate member 490. Thelubricant on the surface of the elongate member 490 allows the elongatemember 490 to more easily slide relative to objects (e.g., tissue,introducer, etc.) that it comes in contact with during a medicalprocedure. The lubricating system 700 is advantageous in that itautomatically applies lubricant onto the elongate member 490 as theelongate member 490 is advanced through the lubricating system 700.

FIG. 69 illustrates another lubricating system 700 in accordance withother embodiments. The lubricating system 700 includes a bladder 730attached to a distal end of the anti-buckling device 500. Thelubricating system 700 further includes a luer lock 732 with a checkvalve 734, which allow a syringe to fill the bladder 730 with fluid(e.g., saline). In particular, the check valve 734 is configured so thatwhen the syringe is not coupled to the bladder 730, fluid inside thebladder 730 is prevented from escaping out of the bladder 730 throughthe check valve 734. When the syringe is coupled to the bladder 730, thecheck valve 734 is pushed open by the syringe, thereby allowing thesyringe to deliver the fluid into the bladder 730. The lubricatingsystem 700 also includes a flow restrictor 736 at the bottom of thebladder 730 for allowing fluid to be applied onto the surface of theelongate member 490 in a controlled manner. In some embodiments, theelongate member 490 may optionally include a hydrophilic coating so thatthe elongate member 490 may interact (e.g., dissolve) with the saline.The dissolved coating becomes a lubricant for lubricating the elongatemember 490. In other embodiments, the fluid in the bladder 730 mayitself be the lubricant, in which case, the lubricant is applieddirectly onto the elongate member 490 by the flow restrictor 736.

In other embodiments, the lubricating system 700 of FIG. 69 mayoptionally further include a brush 740 attached to the bottom of theflow restrictor 736 (FIG. 70). During use, the brush 740 applies thefluid from the bladder 730 onto the elongate member 490. In otherembodiments, the device 700 itself may function as an applicator. Insuch cases, the user may hold the applicator 700 and may apply fluid inthe bladder onto the surface of the elongate member 490 before it isinserted into a patient. The fluid may interact with a hydrophiliccoating on the elongate member 490 to form lubricant. Alternatively, thefluid itself may be lubricant that is applied directly onto the elongatemember 490.

In other embodiments, the lubricating system 700 may include a container(e.g., saline bag) 750 that is compressed by a pressure cuff 752, andfluid from the container 750 is then routed to the drivable assembly 184(FIG. 71). In the illustrated embodiments, the drivable assembly 184 hasinternal plumbing and a flow restricting nozzle that would allowdroplets to escape. As droplets are escaped from the drivable assembly184, they travel down the body of the elongate member 490. In somecases, the elongate member 490 may be oriented at an angle 756 that isat least 15° relative to a horizontal axis, so that the droplets mayflow down the elongate member 490 more easily. The droplets travellingdown the body of the elongate member 490 will reach eyelets (e.g., ABeyelets) 754 that are placed around the elongate member 490. Each eyelet754 is configured to capture a small amount of fluid so that theelongate member 490 can absorb later. As more and more droplets leavethe drivable assembly 184, all of the eyelets 754 will eventually befilled up, and the elongate member 490 will be completely hydrated. Insome embodiments, each eyelet 754 has an optimized surface area (orpressure head to viscosity ratio) for capturing a desired amount offluid. The eyelets 754 may be coupled to the anti-buckling device 500 insome embodiments, in which case, the eyelets 754 may be considered to becomponents of the anti-buckling device 500. For example, each eyelet 754may be implemented at a respective holder 540 in the anti-bucklingdevice 500. Also, in some embodiments, the holders 540 themselves may beconsidered to be the eyelets 754. In other embodiments, the eyelets 754may be considered components of the lubricating system 700.

In other embodiments, a hydrogel 768 may be manually applied onto theelongate member 490 via a gauze or cotton pad at several discretelocations through openings 770 of the anti-buckling device 500 (FIG.72). As the anti-buckling device 500 is extended or collapsed, thehydrogel 768 is spread out along the length of the elongate member 490through the holders 540. In some embodiments, the holders 540 haveeyelets that store a small amount of hydrogel for later use.

In further embodiments, the lubricating system 700 may include a gelcompartment 780 proximal to an incision site for applying gel to theelongate member 490 (FIG. 73). The gel compartment 780 includes an inlet782 for filling the compartment 780 with a gel substance 784. Duringuse, as the elongate member 490 is inserted distally, it picks up thegel substance 784. In some embodiments, the elongate member 490 mayoptionally include a hydrophilic coating so that the elongate member 490may interact (e.g., dissolve) with the gel. The dissolved coatingbecomes a lubricant for lubricating the elongate member 490. In otherembodiments, the gel 784 may itself be the lubricant, in which case, thelubricant is applied directly onto the elongate member 490 by the gelcompartment 780. In some embodiments, the gel compartment 780 may becoupled to a distal end of the anti-buckling device 500 through anadaptor 786. Also, in some embodiments, if the elongate member 490includes a sheath surrounding a catheter member, the gel compartment 780may be placed proximal to the introducer sheath.

FIG. 74 illustrates another lubricating system 700 in accordance withother embodiments. The lubricating system 700 includes a collapsibletube 800 that contains gel 802. The lubricating system 700 also includesone or more inlets in fluid communication with the tube 800 fordelivering the gel 802 into the tube 800. In the illustratedembodiments, the collapsible tube 800 is incorporated into the center ofthe anti-buckling device 500. During use, the elongate member 490 isinserted through the collapsible tube 800 at the anti-buckling device500. The inlet(s) 804 is then used to deliver gel into the tube 800. Theanti-buckling device 500 is then extended and collapsed several times toevenly spread out the gel onto the surface of the elongate member 490before the elongate member 490 is inserted into the patient. In someembodiments, the collapsible tube 800 may be implemented using a rigidtelescoping tube, a flexible accordion tube, or a bellow.

FIG. 75 illustrates another lubricating system 700 in accordance withother embodiments. The lubricating system 700 includes a plurality ofpockets 820, wherein each pocket 820 has a nozzle 822 that pointstowards the elongate member 490. The pockets 820 may be made from aresilient material, such as polyurethane, and may be attached at severallocations (e.g., at joints between two support members) at theanti-buckling device 500. In the illustrated embodiments, mini pouchesof hydrogel are contained inside the pockets 820. During use, theclosing action of the anti-buckling device 500 squeezes the pockets 820down to eject the gel out of the pockets 820 and onto the surface of theelongate member 490. The anti-buckling device 500 may be extended andcollapsed to distribute the gel through eyelets (e.g., holders 540)along the elongate member 490.

In other embodiments, the lubricating device 700 may be a drape madefrom a resilient material, such as polyurethane. Gel is applied to oneside of the drape, and the drape is used to apply the gel onto theelongate member 490, the anti-buckling device 500, or both. For example,in some embodiments, the elongate member 490 together with theanti-buckling device 500 may be covered by the drape, and the drape isused to apply the gel onto the elongate member 490 and/or theanti-buckling device 500. The drape is then removed from the elongatemember 490 and/or the anti-buckling device 500 before use of thesedevices. The anti-buckling device 500 may be extended and collapsed todistribute the gel through eyelets (e.g., holders 540) along theelongate member 490.

FIGS. 76-77 illustrate another lubricating device 700 in accordance withother embodiments. The lubricating device 700 includes a stabilizingdevice 840 with a base for attachment to the patient or a bed, and acoupling 842 that joins the anti-buckling device 500 to the stabilizingdevice 840. The stabilizing device 840 is configured to limit the motionof the distal end of the anti-buckling device 500 as the elongate member490 is introduced and retracted relative to the patient. In someembodiments, as the catheter is being inserted and retracted, thestabilizer may be subjected to loads that may create a displacement inthe direction of the catheter motion. In the illustrated embodiments,the lubricating device 700 includes a small membrane filled with fluidor gel at the base of the stabilizer 840, which would be actuated by thedisplacement of the stabilizer 840. The hydrating fluid would bedelivered directly through the coupling 842, or can be deliveredelsewhere by incorporating delivery conduits or a spraying mechanism.

FIG. 78 illustrates another lubricating device 700 in accordance withother embodiments. The lubricating device 700 includes a container 860containing fluid or gel. The container 860 is coupled to the stabilizer502, which is described previously. As the elongate member 490 is beinginserted into the patient's skin, the elongate member 490 is extendedthrough the container 860, which applies the fluid or gel onto theelongate member 490. The fluid or gel may directly lubricate the surfaceof the elongate member 490. Alternatively, the fluid or gel may reactwith an optional hydrophilic coating on the elongate member 490 to forma lubricating substance.

In further embodiments, the lubricating device 700 may include amembrane 890 that encapsulates the anti-buckling device 500, wherein themembrane 890 is filled with fluid or gel during use (FIG. 78A). Themembrane 890 may have a bellow configuration, which allows the membrane890 to extend and contract together with the anti-buckling device 500.

It should be noted that although the term “catheter” and the term“sheath” are used to describe some of the embodiments of the components,these terms should not be limited to the configuration shown. Forexample, in other embodiments, what was referred to as a “catheter” mayalso be called a “sheath” and vice versa. Also, in some embodiments, theterm “catheter” or the term “sheath” may refer to two or more tubularstructures that are arranged telescopically, or that are coupled to eachother.

VIII. Guidewire Manipulator

Typical manual surgical procedures include the use of a guide wirecurved at its distal tip so that the guide wire can be navigated throughtortuous anatomy by hand-actuated roll and insert motion at its proximalend. Once in place, catheters can be inserted co-axially over the guidewire, the guide wire can be retracted and removed, and the catheter canremain in place providing a delivery device for other minimally invasivetools.

Guide wires or distal protection devices for certain vascular and otherinterventions, may be difficult to position due to their relativelyminimal navigation degrees of freedom from a proximal location, and thetortuous pathways through which operators attempt to navigate them.Additionally, minimally invasive medical procedures can be timeconsuming and physically demanding on an operator causing not onlyoperator fatigue but an excessive amount of exposure of the operator toradiation fields. Providing robotically and remotely precisioncontrolled additional navigation and operational functionality optionsfor minimally invasive interventions, would be useful.

Certain variations of systems as shown in FIG. 1 may include additionalremote motorized control of other pull wire or non pull wire elongatemembers such as guide wires, which utilize roll and insert motions attheir proximal ends to steer their distal tips. Different variations ofelongate member manipulators which can provide motorized actuation of aguide wire or other elongate member are herein described. Many of themanipulator assemblies disclosed herein can be used to provide anymotorized roll and insert or retraction actuation of any elongateinstrument or member including but not limited to ablation probes,needles, scissors, clamps, forceps, graspers, guide wires, catheters,endoscopes, and other minimally invasive tools or surgical instruments.

FIGS. 79A-79D illustrate different views of a variation of an elongatemember manipulator 1100. The elongate member manipulator 1100 includes aset of right and left motor actuated rotary members 1124, 1104. Therotary members can be used to robotically control the insertion andretraction of an elongate member, e.g., a guide wire, along alongitudinal axis of the elongate member and/or the roll or twist of theelongate member about a longitudinal axis of the elongate member. Inthis variation, the rotary members are in the form of cylinders or feedrollers. However, the rotary members may include any other devicesuitable for providing rotary motion including belts.

As shown in FIG. 79A, the elongate member manipulator 1100 includes aright roller assembly 1122 and a left roller assembly 1102. Each rollerassembly provides rotation and up-down or axial translation to theirrespective feed rollers 1124, 1104. The left roller assembly 1102includes the left spline actuator 1106 and the left leadscrew actuator1108. The right roller assembly 1122 includes a right spline actuator1126 and a right leadscrew actuator 1128.

As illustrated in FIG. 79C, (a cross sectional view of the elongatemember manipulator 1100), the internal elements of the left splineactuator 1106 may be identical to the internal elements of the rightspline actuator 1126. Also, the internal components of the leftleadscrew actuator 108 may be identical to the internal components ofthe right leadscrew actuators 1128. Thus both right and left splineactuators 1126, 1106 may include a spline shaft 1174, coupled to aspline nut 1176 which is driven by a gear train which will be describedin further detail below. Similarly, the right and left leadscrewactuators 1128, 1108 may include a leadscrew shaft 1184, coupled to aleadscrew nut 1186, driven by a similar gear train.

The spline nut 1176 and leadscrew nut 1186 may be sized such that twoaxially adjacent gears can create a gear stack that covers the entireaxial length of each nut. Thus the left spline actuator 1106 may includea left spline gear stack 1110, which acts as one gear driving the splineshaft 1174 which in turn drives the left roller 1104. The left leadscrewactuator 1108 may also have a similar left leadscrew gear stack 1114which functions in a similar manner. In alternative variations, asmaller spline nut and smaller leadscrew nut may be utilized allowingfor a single gear to be used as opposed to a gear stack.

The right roller assembly 122 may include gears that are driven (in amanner as will be described below), and instead of stacking two adjacentgears, the right spline actuator 1126 can include a smooth shaft 1132and a right spline output gear 1130. The right leadscrew actuator 1128can include a smooth shaft 1138 and a right leadscrew output gear 1136.The right spline output gear 1130 and right leadscrew output gear 1136are coupled to the spline shaft 1174 and leadscrew shaft 1184respectively and the gears drive the motion of the roller 1124.

In operation, the right and left rollers 1124, 1104 may rotate atsubstantially the same rate but in opposite directions to facilitateinsertion or retraction of an elongate member, such as the guide wire1060 (shown in FIGS. 79A-79B and 79D). Idler gears may be used to couplethe motion of the right and left actuator assemblies 1122, 1102.

As shown in FIG. 79B the elongate member manipulator 1100 may include aright spline coupling gear 1134, a left spline coupling gear 1135, aright leadscrew coupling gear 1140 and a left leadscrew coupling gear1141. To rotate the rollers 1104, 1124, the left spline gear stack 1110is driven by a spline belt 1112, which in turn can be directly driven bya motor or driven indirectly by a series of gears, belts or pulleys (notshown). As previously described, this rotation will cause a directrotation of the left roller 1104. Simultaneously, the left spline gearstack 1110 may use the coupling gears to drive the right roller 1124 inan opposite direction to that of the left roller 1104.

FIG. 79D, shows a top view of the elongate member manipulator 1100 (thefeed rollers are not shown for clarity). In this example, the leftspline gear stack 1110 is driven in the CW direction 1150, the leftspline coupling gear 1135 will rotate in the CCW direction 1152,rotating the right spline coupling gear 1134 in the CW direction 1150,and the right spline output gear 1130 in the CCW direction 1152. If allthe gears are sized equally, the left spline gear stack 1110 and rightspline output gear 1130 will rotate at the same rate in oppositedirections, rotating the rollers 1104, 1124 at equal rates in oppositedirections, which would drive the guide wire 1060 in a forwardpropelling motion 1159. Reversing the direction of the spline belt 1112would reverse the directions of both the left spline gear stack 1110 andright spline output gear 1130, and as a result, reverse the direction ofrotation of the rollers 104, 124, thereby driving the guide wire in thereverse propelling motion.

The leadscrew actuators 1108, 1128 may function in a similar manner butalternatively cause one roller to translate upwards while the otherroller translates downwards at a substantially similar rate. This motionwill drive the guide wire 1060 in a roll or torque motion. The clockwiseor counterclockwise directions of roll are dependent on the direction ofrotation of the leadscrew belt 1116. Both insert/propelling motion androll/torque motion can be accomplished with varying speed rates for eachaxis. The propelling and torque axes motions can be simultaneous, orthey can be independent of each other.

FIG. 81 illustrates a cross sectional view of one variation of a rolleractuator 1170 that may be utilized to provide motorized rotation andtranslation actuation of one or more rotary members, such as a feedroller. Such a roller actuator may be utilized to provide rotation andtranslation actuation of various rollers, including, for example, therollers of elongate member manipulator 1100 described above.

The roller actuator 1170 includes a one or more spline actuators 1172having a spline shaft 1174 coupled to a spline nut 1176 mounted onspline nut bearings 1178. The spline nut 176 is rotated by a spline gear1180 which can either be directly motor driven or indirectly motordriven via a series of gears, belts or pulleys (not shown). The splineshaft 1174 may be fixably coupled to a rotary member such as a feedroller 1104, so that the rotation of the spline nut creates rotation ofthe feed roller. A single leadscrew actuator 1182 which includes aleadscrew shaft 1184, leadscrew nut 1186, leadscrew nut bearings 1188,and a leadscrew gear 1190 is provided adjacently below the splineactuator 1172 to provide up-down translation of a feed roller. Theleadscrew nut 1186 is driven by the leadscrew gear 1190 which can eitherbe directly motor driven or indirectly motor driven via a series ofgears, belts or pulleys (not shown). Rotation of the leadscrew nut 1186lifts and lowers the leadscrew shaft 1184 and spline shaft 1174,creating the up and down lift or axial translation of the feed roller.

In certain variations, the spline shaft 1174 and leadscrew shaft 1184may be coupled so that rotation of one may cause rotation of the other.Because the spline shaft 1174 is constructed as a spline, it can bedriven up and down by the leadscrew shaft 1184 without lifting thespline nut 1176, spline bearings 1178, or spline gear 1180. To actuateonly rotation of the feed roller, both spline nut 1176 and leadscrew nut1186 may be rotated at the same rate. As a result, the leadscrew shaft1184 will rotate at the same rate as the leadscrew nut 1186 so that nolift motion will occur. To actuate only lift of a feed roller, theleadscrew nut 1186 may be rotated without movement of the spline nut1176. Alternatively, simultaneous rotational and translational motion ofa feed roller may be provided by slowing and speeding up the leadscrewnut 1186 relative to the spline nut 1176 or vice versa.

In an alternative variation, the spline shaft 1174 and the leadscrewshaft 1184 may not be coupled so that movement of the spline actuator1172 and the leadscrew actuator 1182 are completely independent.Alternatively, the spline shaft 1174 and leadscrew shaft 1184 could befree to rotate independently by joining the two shafts in a ball andsocket type configuration. Additional bearing support may be utilized insuch a variation.

FIGS. 80A-80B illustrate examples of feed rollers in use, showing how anelongate member, e.g., a guide wire 1060, may be actuated by the feedrollers 1124, 1104. FIG. 80A illustrates a top view of a pair of feedrollers 1124, 1104 illustrating how the feed rollers can rotate abouttheir axes in opposite directions 1152, 1150 to drive a guide wire 1060in a backwards propelling motion or a retract motion 1158. The feedrollers can also be rotated in opposing directions to provide forwardpropelling or insert motion (not shown). FIG. 80B shows a front view ofthe feed rollers 1124, 1104 illustrating how the feed rollers cantranslate axially along their axes in opposite translation directions1154 to torque or roll 1160 the guide wire 1060.

Forward or reverse insert/retract motion 1158 is dependent on thedirection of rotation 1152, 1150 of the rollers 1124, 1104 whileclockwise or counter-clockwise roll motion 1160 is dependent on thedirection of up and down linear or axial translation 1154 of the rollers1124, 1104. Both insert/retract motion and roll motion can beaccomplished with varying speed rates for each axis. The insert and rollactuations can be independent of one another, or they may occursimultaneously. Also simultaneous roll and insert actuation can bedesirable in part because traditional manual procedures are performed inthat manner. Currently physicians articulate and steer manual guidewiresby inserting and rolling simultaneously resulting in more of a spiralinginsertion. It can be desirable for robotic systems to emulate manualprocedures for physician ease of use.

In alternative variations, insert motion can be provided by feed rollerswhile roll motion actuation may be provided by clamping the guide wirein a clamp mechanism and rolling the clamp mechanism. In this variationroll and insert motion may be alternated between insert and roll withtypical clutching mechanisms that release grip from one actuatorassembly while the alternate assembly provides actuation. For example,in a feed roller variation with clutching, feed rollers used to actuateinsert may release the guide wire while actuators providing rotation toroll the guide wire. The release of the guide wire from one actuatorduring activation of the alternate actuator in systems which use feedrollers for insert but roll the guide wire with a separate mechanismallows the guide wire to overcome friction experienced from the feedrollers during roll actuation. If insert and roll are simultaneouslyactuated the wire may be gripped in the insert feed rollers which couldresult in the stripping or winding up the wire.

Systems which clutch between insert and roll actuators typically releasegrip of the guide wire by one actuator to allow the alternate actuatorto grip the guide wire. By releasing the wire, any tracking of guidewire position using encoders may be lost which could decrease theaccuracy of position tracking. Also, additional actuators may result ina more complex or more costly system.

In certain variations, a guide wire 1060 may be loaded into the elongatemember manipulator 1100 by being back or front loaded or fed into thefeed rollers 1104, 1124 while rotating the feed rollers 1104, 1124 in aninsert or retract motion.

In certain variations, the elongate member manipulator 1100 may bedesigned such that at least a portion of the elongate member manipulator1100 remains in a sterile field. For example, the motors and drivemechanisms or drive components of the elongate member manipulator may besituated in a non-sterile field and a sterile drape could be placedin-between the drive components and the feed rollers. Thus, the elongatemember, e.g., a guide wire, held by the feed rollers will remain sterilefor insertion into a patient's anatomy. In certain variations,components of an elongate member manipulator which are meant to remainsterile may be disposable and/or the complexity of such components maybe minimized in order to minimize or reduce overall costs of suchdisposable components or the elongate member manipulator.

Referring back to FIGS. 79A-79C, one variation of a sterile drape 1070used to create a sterile field that includes the feed rollers 1104, 1124and guide wire 1060 is illustrated. All other components could bepositioned in a non-sterile field.

FIG. 82 shows an example of the sterile drape 1070 installed between theleft feed roller 1104 and the spline shaft 1174. The sterile drape 1070may be designed such that the roller 1104 can be removeably replaceablewhere the drape 1070 could be placed over the spline shaft 1174 and therollers could be installed over the drape in the sterile field. Thesterile drape 1070 could have a sterile drape bushing 1072 that isfixably attached to the drape 1070. The roller 1104 could be coupled tothe bushing 1072 via a roller shaft 1105 extending through the bushing1072 which is coupled to the spline shaft 1074 in the non-sterile field.The roller shaft 1105 and spline shaft 1074 could be coupled by keyingeach shaft to mate, thus allowing rotation of the spline shaft 1074 tocause a one to one rotation of the roller shaft 1105. The key can beshaped as a hexagon, triangle, star, cross or any other shape. Theroller 1104 may rotate relative to the bushing and may translate up anddown like a piston. A fastener may be provided to secure the roller 1104in place to prevent slippage in the axial direction. Alternatively, theroller shaft 1105 may be threaded and coupled to a threaded hole in thespline shaft 1174. As the roller 1104 moves up and down, a left rollergroove 1123 on the roller may create a labyrinth seal and maintain asterile boundary between the bushing 1072 and roller 1104. Optionally,an o-ring or lip seal can be placed between the bushing 1072 and roller1104 to prevent fluid ingress and create an improved sterile boundary.The sterile drape 1070 could provide for a sterile interface for theright feed roller 1124 in the same manner.

FIGS. 83-83A illustrate another variation of an elongate membermanipulator 1200 which includes rotary members in the form of belts. Theelongate member manipulator 1200 is shown mounted on an instrumentdriver 16. The elongate member manipulator 200 may by utilized to feedan elongate member, such as guide wire 60, co-axially into a guidecatheter splayer 1052. The guide wire 1060 may be fed into a supporttube 1056 which subsequently feeds into the guide catheter splayer 1052,and ultimately into a guide catheter (not shown). In certain variations,the elongate member manipulator may be mounted on the instrument driveralong with a guide and/or a sheath splayer/catheter or the elongatemember manipulator may be mounted alone. Optionally, the elongate membermanipulator may be utilized to feed an elongate member, such as guidewire, co-axially into a sheath and or catheter. Optionally, the elongatemember manipulator may be utilized to feed an elongate member, such asguide wire, directly into a patient's body or anatomy.

FIG. 84 illustrates the elongate member manipulator 1200 in an openhinged configuration. The elongate member manipulator can include adrive assembly and an elongate member holder. The components of theelongate member holder include a drive belt assembly 1210 and an idlerbelt assembly 1220. Both belt assemblies include belts 1212, 1222 withpulleys 1214, 1224. The drive pulley 1084 may be directly driven by aninsert servo motor 1102 or other mechanism to turn the drive belt 1212.The idler belt 1222 is free to rotate about the idler pulley 1224. Thebelts may be constructed from various materials known to person havingordinary skill in the art. The belts may have various dimensions. Forexample, about 1″ wide Texin® or silicon rubber, durometer 90A profiledtiming belts may be utilized covering a length of about 4.5″ fromopposite outer diameter edges of the belt. Other variations may usealternative widths, other dimensions, and materials with alternativedurometers for the belts. In one variation the belts can be constructedfrom any gamma sterilizable material which is well known in the artincluding but not limited to thermoplastics such as ABS or PET,fluoropolymers such as polyvinyl fluoride, polymides, polystyrenes,polyurethanes, polyesters, or polyesters. Optionally, bands or feedrollers could be used in place of belts.

As shown in FIGS. 85A, 85B and 85C, the drive assembly can include anupper slide assembly 1234, a lower slide assembly 1230, an insert motor1202, and a roll motor 1204, as well as a set of rails, a rack and apinion (not shown here but described in detail below). In use, asillustrated in FIGS. 84 and 85A, the upper slide assembly 1234 can hingeopen a plurality of degrees for workflow clearance, the guide wire 1060can be placed on the drive belt 1212, and the elongate membermanipulator 1200 or system can be closed so that the guide wire 1060 isheld between the drive belt 1212 and the idler belt 1222. This allows aguide wire to be loaded into the elongate member manipulator 1200anywhere along the length of the guide wire 1060, which may expedite theloading procedure instead of being restricted to load the wire byfeeding the wire from the back of the system. Also the guide wire can beloaded when the belts are in any position. For example, the drive belt1212 may be at an arbitrary position such that the drive motor 1202 doesnot require any type of initialization or homing before installation ofthe guide wire 1060. Additionally a guide wire can be removed from theelongate member manipulator 1200 or system mid procedure if the operatordesires to switch from using the robotic manipulator to manual controlof the guide wire.

In alternative variations a guide wire can be backloaded into amanipulator. A back loaded guide wire would be retracted or pulled outof a patient's body before removing the guide wire from the manipulatorto switch to manual control

To ensure that the upper slide assembly 1234 and lower slide assembly1230 stay closed during operation, a captive screw 1254 can be used. Avariation including a captive screw 1254 is shown in FIGS. 85B-E whichillustrate an isometric view of the elongate member manipulator 1200with only the drive belt assembly 1210 shown (idler belt assembly notshown for clarity). FIG. 85B illustrates the elongate member manipulator1200 in an open position, FIG. 85C illustrates the elongate membermanipulator 1200 as it is partially closed, and FIG. 85D shows theelongate member manipulator 1200 closed and locked. The captive screw1254 remains captive with the upper slide assembly 1234 and locks into athreaded hole 1256 in the lower slide assembly 1230. FIG. 85Eillustrates a cross section of the elongate member manipulatorillustrating the operation of the captive screw 1254. In alternativevariations, a latch, fastener or other type of locking, fastening orlatching mechanism may be used instead of a captive screw.

As illustrated in FIG. 85A, once the guide wire 1060 is loaded and heldbetween the drive belt 1212 and the idler belt 1222, the insert motor1202 drives the drive pulley 1214, turning the drive belt 1212 andpropelling the guide wire 1060 forward or backwards (insert or retract)depending on the rotational direction of the motor and pulley. Withsufficient frictional pinching, gripping, pressing, or holding forceholding the guide wire 1060 between the drive belt 1212 and idler belt1222, the idler belt 1222 will turn at the same rate as the drive belt1212, and the belts will hold the guide wire 1060 such that laterallinear movement or displacement of the guide wire relative to the beltsmay be eliminated, minimized or reduced.

FIGS. 86A-86C illustrate various views of the elongate membermanipulator 1200 showing various components of the elongate membermanipulator that function to provide roll actuation of the guide wire1060. (Some components of the elongate member manipulator 1200 arehidden for clarity.)

FIG. 86A illustrates an end view of the elongate member manipulator1200. FIGS. 86B-86C illustrate perspective views of the elongate membermanipulator 1200 providing different angles showing the lower slideassembly 1230 and the upper slide assembly 1234. The lower slideassembly 1230 and upper slide assembly 1234 may each be attached tolinear rails 1240. The lower slide assembly 1230 includes the insertmotor 1202 and a slip detection encoder 1204. The drive belt assembly1210 attaches to the lower slide assembly 1230 while the idler beltassembly 1220 attaches to the upper slide assembly 1234. Both lower andupper assemblies 1230, 1234 have a rack 1232, 1236 that is coupled to apinion 1238 driven by a roll motor 1206. The roll motor 1204 is mountedstationary relative to the instrument driver so that when the pinion1238 is turned, the slide assemblies 1230, 1234 move or translate inopposing directions, driving both the drive belt assembly 1210 and theidler belt assembly 1220 in opposing translational directions 1154. Thismotion will roll, rotate or torque the guide wire 1060 as shown by thearrow 1160. Translation of the drive belt assembly 1210 and idler beltassembly 1220 in directions opposite those shown in FIG. 86A wouldresult in roll of the guide wire in the direction opposite that of arrow1160.

In an alternative variation (not depicted), either the upper or lowerslide assemblies could be coupled to a leadscrew so that motorizedrotation of the leadscrew would result in translation of one slideassembly relative to the other. Roll and insert can be independentlyactuated or actuated simultaneously as described previously.

When the elongate member manipulator 1200 is in a closed configurationholding the guide wire 1060, a sufficient pinching force between thedrive belt 1212 and idler belt 1222 may be necessary to provide adequatefrictional force to actuate insert, or retraction, and/or roll of theguide wire 1060. As various guide wires 1060 with varying wire diametersmay be loaded into the elongate member manipulator 1200, it may bedesirable to adjust the pinching force such that the applied pinchingforce is high enough to provide for insert and roll actuation while lowenough to prevent damage or buckling of the guide wire 1060.

Thus, in certain variations, the upper slide assembly 1234 of anelongate member manipulator can include a hinge 1242 and a suspensionmechanism 1244. FIGS. 87A-87B show a left side view of an elongatemember manipulator 1200 with the suspension mechanism 1244 in an openand closed configuration respectively, while FIG. 87C shows a crosssection of the assembly 1234 with the suspension mechanism 1244. Thesuspension mechanism 1244 may include a lever arm 1246, a lever shaft1248, a lever spring 1250 and a tightening nut 1252. The suspensionmechanism 1244 may provide a mechanism by which the force applied by thelever spring 1250 to hold the guide wire between the idler belt assembly1220 and the drive belt assembly 1210 may be adjusted in order toaccommodate a variety of guide wire diameters while providing sufficientpinching force for a variety of guide wire diameters.

As illustrated in FIG. 87B, the tightening nut 1252 may be used tocontrol the swing of the lever arm 1246 to adjust the grip force betweenthe upper slide assembly 1234 and the lower slide assembly 1230 to applythe necessary grip force for various wire diameters and to provide anincreased force ratio for wire compression. By way of example but notlimitation, if a 2 to 1 force ratio could be applied where a 20 lb wireload was required, a 10 lb spring would be applied to the lever. Therange of guide wire diameters that could be accommodated for thisexample may range from about 0.014″−0.038″.

FIGS. 88 and 89 illustrate a pair of elongate member brackets or wireholders 1260, 1262 that can be used to prevent a guide wire 1060 orother elongate member from sliding or slipping laterally or in thedirection of slide assembly or belt assembly translation while the guidewire or elongate member is being rolled or twisted. Such wire holdersmay hold or grip a guide wire in addition to or in place of thefrictional pinching force provided by the rotary member, rollers orbelts. FIG. 88 illustrates the elongate member manipulator 1200 with apair of wire holders 1260, 1262 where both the elongate membermanipulator and the wire holders are in an open configuration. FIG. 89illustrates the manipulator 1200 and wire holders 1260, 1262 in a closedconfiguration.

The wire holders 1260, 1262 may be in the form of simple clamps or otherconfigurations that can open and close to load and hold the guide wire1060 and/or the guide wire support tube 1056. Cut outs in the holdersmay be sized to allow for the guide wire 1060 and/or the valve assembly1352 to be held in place along a longitudinal axis of a belt assemblywhile also allowing the guide wire to move in a propelling motion or aroll motion without excess friction. In order to prevent or minimize anyundesired slippage in the translation direction 1154 (See FIG. 86A)during roll of the guide wire, which may result from the toleranceprovided by such cut outs, dimensions of the wire holders can be varied.The wire holders may be designed to minimize or prevent such slippage inthe translation direction while also minimizing or preventing propellingand/or roll friction. Additionally, lubricants could be used to minimizeor prevent propelling and/or roll friction while still minimizing orpreventing slippage in the translation direction.

Alternatively, some situations may require minimizing lubrication of theguide wire in order to provide adequate gripping of the wire. In onevariation, as the guide wire is retracted or de-inserted from thepatient, sections of the guide wire may become coated with blood orfluid. When the sections are retracted between the drive belt assembly1210 and idler belt assembly 1220, the guide wire 1060 may becomeslippery preventing the guide wire manipulator 1200 from adequatelyrolling and de-inserting the guide wire 1060. Thus, an absorbentmaterial (not shown) may be integrated or included into the wire holder1260 to remove blood or fluid from the guide wire 1060 as it isretracted into the guide wire manipulator 1200. In certain variations,the absorbent material could be integrated only in the distal wireholder 1260 and not the proximal wire holder 1262 since the length ofguide wire proximal to the drive and idler assembly belts 1210, 1220 isno longer engaged in the guide wire manipulator 1200. In alternativeembodiments the absorbent material can be integrated into both wireholders 1260, 1262 or only the wire holder 1262 preventing any outsidefluids from coating the guide wire during the insert forward propellingactuation motion as well or to provide additional fluid removal of theguide wire during retraction. The absorbent material can included but isnot limited to any type of sponge, wicking cloth, or polymer.Alternatively, a wiper mechanism can be integrated into the wire holders1260, 1262.

In addition to the slippage that may occur during roll motions, a guidewire 1060 or other elongate members may also be susceptible to slippagebetween the drive belt 1212 and idler belt 1222 in the direction ofinsertion or retraction motion while the guide wire is being propelledforward or backward, despite maximizing pinching force and optimizingbelt materials. Roll and/or insert motors 1202, 1204 can be providedwith encoders to measure the commanded insert and roll of a guide wire.To help improve the accuracy of this measurement, a mechanism forslippage detection during insert or retraction may be provided.

Referring back to FIG. 84, in certain variations, the elongate membermanipulator 1200 may include a drive side slip roller 1216 and idlerside slip roller 1226 for guide wire insertion or retraction tracking.One or more fo the drive and idler slip rollers 1216, 1226 may bedecoupled from motion of the drive and idler belts 1212, 1222. The driveroller 1216 is shown directly coupled to an encoder 1206 (illustrated inFIG. 85) for guide wire slip detection. The drive side slip roller 1216can be constructed from a harder material, e.g., PET, and the idler sideslip roller 1226 can be constructed from a softer material, e.g., anopen celled rubber. The harder PET will not deform from contact with theguide wire 1060 preventing the outside diameter of the drive side sliproller 1216 from varying. Since the insertion or retraction distance maybe calculated from encoder counts (where encoders are used) and rollerdiameter, it is important that the roller coupled to the encoder benon-deformable material such as PET. Conversely, the softer material,e.g. the open celled rubber could allow for compression compliance whichwill assist with guide wire grip. The combination of materials allowsfor a tight grip on the guide wire 1060 during insertion/retraction, butprovides for a smooth slip during roll. Alternative materials could beused to allow for this smooth slip while still providing adequategripping of the wire during insertion and retraction. Any type of gammasterileizable material can be used which can be chosen based ondurometer. Alternatively, the drive side slip roller 1216 may beconstructed form a softer material and the idler side slip roller 1226may be constructed from a harder material and the encoder may be shouldbe coupled to the idler slip roller 1226.

In order to maximize workflow while keeping the guide wire 1060 and beltassemblies 1210, 1220 in the sterile field, a mechanism that allows foreasy removal and replacement of the sterile components, including theguide wire and belt assemblies, may be provided. The belt assemblies maybe detachable or removable from the slide assemblies and/or remainingcomponents of the elongate member manipulator such that a drape or othersterile barrier may be installed or inserted between the sterilecomponents, e.g., the belt assemblies, and the non-sterile components,e.g. the slide assemblies. Additionally, the sterile components may bedisposable. Accordingly, the complexity of the sterile components orassembly of the elongate member manipulator may be minimized to reducecost, and many components of the elongate member manipulator, such ascertain motors, gears, capstans, etc., may be designed or configuredsuch that they remain in the non-sterile field.

FIGS. 90A-90C illustrate the drive belt assembly 1210 and the idler beltassembly 1220 as sterile assemblies of minimal complexity having pulleysand belts, where the assemblies can be removed and replaced easily. FIG.90A illustrates the elongate member manipulator 1200 with the drive beltassembly 1210 and the idler belt assembly 1220 removed or detached fromthe slide assemblies 1230, 1234. The belt assemblies may include a driveshaft 1264 having a cross pin 1266 to key into socket 1268 provided inthe slide assemblies 1230, 1234. Alternatively a spline or taper elementcould be used. A captive nut 1270 may be attached to the disposabledrive and idler belt assemblies 1210, 1220 and remain in the sterileenvironment. FIG. 14B shows a cross section of the elongate membermanipulator where the drive belt assembly 1210 is fully installed andthe idler belt assembly 1220 partially installed in the slide assemblieswhile FIG. 90C shows the same cross section with both belt assemblies1210, 1220 fully installed in the slide assemblies.

FIGS. 91A-C illustrate another variation of an elongate membermanipulator 1300. The elongate member manipulator 1300 may be mounted toa manipulator mounting bracket 1058 which is mounted to the instrumentdriver 1016. The elongate member manipulator 1300 may be utilized tofeed an elongate member, such as guide wire (not shown), co-axially intoa support tube 1056 which subsequently feeds into the guide cathetersplayer 1052, and ultimately into a guide catheter 1054. In certainvariations, the elongate member manipulator 1300 may be mounted on theinstrument driver 1016 along with a guide and/or a sheathsplayer/catheter or the elongate member manipulator 1300 may be mountedalone.

FIGS. 91D-H illustrate various views of the elongate member manipulator1300. FIGS. 91D-E show perspective views of the elongate membermanipulator 1300 in a closed configuration, FIG. 91F shows a perspectiveview of the elongate member manipulator 1300 in an open configuration,and FIGS. 91G-H show right and left side views of the elongate membermanipulator 1300 in a closed configuration.

The elongate member manipulator 1300 may include an upper slide assembly1334, a lower slide assembly 1330, a drive belt assembly 1310, an idlerbelt assembly 1320, an insert motor 1302, a roll motor 1304, and anelongate member support 1332. The insert motor 1302 may be fixablymounted to the upper slide assembly 1334 while the roll motor 1304 maybe fixably mounted to a manipulator base 1306 or to the lower slideassembly 1330. The elongate member support 1332 may also be mounted tothe manipulator base 1306 or lower slide assembly 1330 using one or morescrews 1336 or other attachment mechanisms. The drive belt assembly 1310may be removeably coupled to the upper slide assembly 1334 while theidler belt assembly 1320 may be removeably coupled to the lower slideassembly 1330 both using one or more screw assemblies 1372 or otherattachment mechanisms.

FIGS. 92A-B illustrate perspective views of a variation of an idler beltassembly 1320. In this variation, three small, separate idler belts 1322are free to rotate about passive idler pulleys 1324 rotatably mounted toan idler frame 1326. The multiple small idler belts 1322 may be spacedapart allowing the elongate member support 1332 to be inserted,positioned or to extend between two or more of the belts 1322 as shownin FIG. 91F. In certain variations, two or more idler belts may beutilized in an idler belt assembly.

FIGS. 93A-93D illustrate perspective top and bottom views of a variationof a drive belt assembly 1310. In this variation, the serpentine belt1312 is snaked in a “serpentine” like or weaving manner around one ormore of the drive pulley 1319, the serpentine idler pulleys 1314 and thereverse idlers 1315, which are each rotatably mounted to the drive frame1316. This provides a mating, multiple segmented belt that may makecontact with the multiple small idler belts 1322 while still providingclearance for the elongate member support 1332. The drive pulley 1319may be fixably coupled to a drive shaft 1318. Materials for variouscomponents for both the idler belt assembly 1320 and drive belt assembly1310 could include but are not limited to Polyurethane 90A for the belts1212, 1322, and anodized Al 6061-T6 for the frames 1316, 1326 andpulleys (1315, 1315, 1319, 1324). Other similar materials may beutilized.

FIGS. 94A-94B show another variation of an elongate member support 1332that may be used in the elongate member manipulator 1300. FIG. 94Billustrates a cross-sectional top view of the elongate member support1332. Certain portions of the support 1332 or the entire support 1332may be sterilizable. The support 1332 may include a support body 1334and one or more screws 1336 embedded in support rods 1338 which arecontrolled by screw knobs 1340 may also be provided on the support 1332.The support body 1334 may have arms or protrusions 1341 and/or grooves1342 for holding an elongate member. In one variation, the elongatemember support 1332, the support rods 1338 and/or the screw knobs 1340may be made of a softer material such as a PET (poly ethyleneterephthalate) thermoplastic, while the screws 1336 may be made ofstainless steel. In alternative variations, the above components may bemade from a variety of materials and the materials could vary based ondesired hardness of materials as well as costs.

During operation, the upper slide assembly 1334 may hinge or rotate openas shown back in FIG. 91F to allow for the guide wire 1060 to beinstalled onto the elongate member support 1332. The elongate membersupport 1332 provides a holder for the guide wire 1060 while centeringthe guide wire 1060 in a desirable position. The multiple beltconfiguration provided by the idler belts 1322 allows for positioningand clearance of the elongate member support 1332 in between the idlerbelts 1322. The positioning of the elongate member support 1332 may besuch that the guide wire 1060 is supported while still being adequatelyheld between the multiple small idler belts 1322. Also various elongatemember supports could be provided each with different sized grooves toallow for use of varying sized guide wires. The elongate member supportsmay also be sterile and/or disposable or they may be non-sterile. Forexample, the elongate member support 1332 could be provided as a steriledisposable and be removed and replaced with an alternatively sizedelongate member support if a different sized guide wire was necessarymid-procedure.

FIG. 94C illustrates an alternative perspective view of the elongatemember manipulator 1300 with an insert motor cover 1303 mounted thereon,FIG. 94D illustrates the same perspective view with the insert motorcover removed, and FIG. 94E illustrates a zoomed in view of the elongatemember manipulator 1300 with the motor cover 1303 removed displaying theinsert motor 1302 mounted to the upper slide assembly 1334. The insertmotor 1302 has a shaft (not shown) which is coupled to helical gear11308, which drives bevel gear2 1309, which is directly coupled to thedrive shaft 1318. The drive shaft 1318 is rotatably mounted to a driveframe 1316. The drive shaft 1318 may be driven by the insert motor 1302,thereby turning the drive pulley (not shown), to actuate the serpentinebelt 1312 in a forwards or reverse direction.

In the closed configuration of the elongate member manipulator 1300, asshown in FIGS. 91D and 91E, the idler belt assembly 1320 and the drivebelt assembly 1310 may hold the guide wire 1060 with enough frictionalforce to propel the guide wire 1060 in the insert or retract directionswhen the insert motor 1302 is actuating the serpentine belt 1312. Themultiple small idler belts 1322 will passively roll in the oppositerotational direction as the serpentine drive belt 1312.

The upper slide assembly 1334 may be actuated by a roll motor 1304 whichcauses the upper slide assembly 1334 to translate relative to the lowerslide assembly 1330 to roll the guide wire 1060 held between the beltassemblies. The roll motor can drive a pinion which is coupled to rackson both the upper and lower slide assemblies 1334, 1330 to actuate thetranslational movement the slide assemblies as previously describedAlternatively, any equivalent type of mechanism such as a leadscrewconfiguration could be used to actuate translation of the upper andlower slide assemblies. The elongate member support 1332 not onlypositions or holds the guide wire 1060 or other elongate member in theelongate member manipulator 1300 as previously described, but it alsoprevents the guide wire 1060 from buckling during guide wire insertion,retraction or roll actuation.

Other variations of the idler belt assembly 1320 could include anynumber of idler belts and pulleys, spaced apart by various distanceswhich may allow for installation or positioning of the elongate membersupport 1332 between the belts. Accordingly the elongate member support1332 could be provided with any number of support protrusions, spaced atany distance, and the drive belt assembly 1310 could be provided withany number of pulleys spaced apart at varying distances to provide for aplurality of windings. The idler belt assembly 1320 and drive beltassemblies 1310 can be configured to have mating belt segments such thatthe distances between each small idler belt 1322 is minimized tomaximize belt contact with the guide wire 1060. The number ofprotrusions provided by the elongate member support 1332 could varybased on the diameter of the elongate member. For example, a greaternumber of protrusions and/or grooves may be provided for an elongatemember having a smaller sized diameter which may require more support toprevent buckling of the elongate member.

Referring to FIGS. 95A-95C, an elongate member manipulator (not shown)can also include a valve holder 1350 which provides a mount for a valveassembly 1352 that encapsulates the elongate member (not shown). Thevalve holder 1350 may include an elongate member holder 1354 and a cover1356. The valve holder 1350 can be mounted to an elongate membermanipulator mounting bracket (not shown) with a screw 1358 and a knob1360. A set of magnets (not shown) may be embedded in the cover 1356and/or in the elongate member holder 1354 to provide a locking mechanismwhich holds the valve holder 1350 in a closed configuration. In othervariations, different types of locking mechanisms such as, but notlimited to clamps, latches, screws, etc., may alternatively be used. Inone variation, the cover 1356, the elongate member holder 1354, and theknob 1360 could be made of a softer material such as a PET (polyethylene terephthalate) thermoplastic while the screw 1358 could be madeof stainless steel and the magnets could be made of neodymium. Inalternative variations the materials could vary based on desiredhardness of materials as well as costs.

If an operator desires to manually control the guide wire 1060 anddecouple it from a robotic elongate member manipulator, such asmanipulator 1300, the drive belt assembly 1310 can be pivoted open asillustrated in FIG. 15F, the valve holder 1350 can be opened, and theguide wire can be removed from the system along with the valve assembly1352 and support tube 1056. The guide wire 1060 can then be rolled andinserted by hand in a manual manner which is well known in the art. Theguide wire 1060 and valve assembly 1352 at any time can be quicklyre-installed in the elongate member manipulator 1300 and roboticoperation can continue seamlessly.

As shown in FIG. 96, both the drive belt assembly 1310 and idler beltassembly 1320 can be removeably replaceable to allow for installation ofa sterile drape 1370 separating the sterile field portion of theelongate member manipulator from the non-sterile field portion of theelongate member manipulator (not shown). FIG. 96 illustrates the drivebelt assembly 1310 and idler belt assembly 1320 being mounted usingscrew assemblies 1372. While similar captive screw mechanisms aspreviously described in reference to FIGS. 90A-C can be used, FIG. 96illustrates an alternative variation. It should be understood thateither variation shown in FIGS. 90A-C and the variation shown in FIG. 96can be used for any elongate member manipulators described herein alongwith any other comparable type of mechanism which is well known in theart.

FIGS. 96A and 96B illustrate cross sectional top views of the drive beltassembly 1310 and idler belt assembly 1320. In one variation, the screwassemblies 1372 can be identical for the idler and drive belt assembliesor can vary in materials and dimensions if necessary to supportdifferent weights of each idler and drive belt assembly.

In an alternative variation, the drive belt assembly 1310 and idler beltassembly 1320 may need to be electrically isolated. Accordingly, thescrew assembly 1372 can include a screw 1374, a knob 1376, an isolationcap 1378, and an isolation sleeve 1380. The screw 1374 can be made ofstainless steel while the knob 1376 and isolation sleeve can be made ofa thermoplastic, such as PET, and the isolation cap can be made of athermoplastic, such as Ultem, providing for electric isolation.Alternatively, any other non-conductive material or thermoplastic can beused to manufacture the knob 1376, isolation sleeve 1380, and isolationcap 1378 or the drive frame 1316 and idler frame 1326 can bemanufactured from a plastic or any other non-conductive materialallowing for the screw assembly to be simplified and manufactured fromstainless steel or any other type of metal.

The variation of elongate member manipulator 1300 shown in FIGS. 91A-91Fprovides the idler belt assembly 1320 and elongate member support 1332on the lower half of the manipulator 1300 while the drive belt assembly1310 is provided on the upper half of the manipulator 1300 such that thedrive belt assembly 1310 may pivot open to allow loading of a guide wire1060. In this variation, the insert motor 1302 may be mounted to theupper slide assembly 1334. In an alternative variation, the drive beltassembly 1310 may be provided on the lower stationary half of themanipulator 1300 so the idler belt assembly 1320 with elongate membersupport 1332 could pivot for guide wire 1060 loading. In the lattervariation, optionally, the insert motor 1302 may remain mounted to thestationary half of the manipulator 1300 which could be desirable.

FIGS. 96C-96E illustrates a representation of an alternative elongatemember manipulator 1700 which provides insert actuation using linearslide motion as opposed to feed rollers or feed belts as described inprevious variations (see e.g., FIGS. 84, 91D, 99, and 104). FIG. 96Cillustrates a perspective view of the guide wire manipulator 1700 whichcan include a pad assembly 1702 mounted on a linear slide 1704 which Theguide wire 1060 can be held between two pads of the pad assembly 1702.To insert or retract the guide wire 1060, the pad assembly 1702 candriven by a motorized leadscrew or motorized belt and pulleyconfiguration (not shown) in the same manner which the guide splayer orsheath splayer is inserted as described in detail in the aforementionedincorporated references. FIGS. 96D and E illustrate side views of theelongate member manipulator 1700 during roll actuation where the twopads of the pad assembly 1702 could be translated relative to oneanother to actuate roll of the guide wire 1060. Sizing of the pads canvary as can pad material to provide the optimum frictional hold on theguide wire 1060 during roll and also during insert. Wire holders (notshown) can also be used to prevent slippage during roll. Insert and rollactuations can be completely independent motions actuated simultaneouslyor individually.

FIG. 97 illustrates another variation of an elongate member manipulator1800 mounted to a variation of an instrument driver 1016. The instrumentdriver includes a guide output plate 1053, a sheath output plate 1043.FIGS. 97 aa-ab illustrate different perspective views of the elongatemember manipulator 1800 shown without a cover 1801 for clarity. Theelongate member manipulator 1800 can be fixably mounted to a manipulatormounting bracket 1858 which in turn can be fixably mounted to the guideoutput plate 1053.

FIGS. 97A1 and 97A3 illustrate different perspective views of theelongate member manipulator 1800 in a closed configuration while FIGS.97A2 and 97A4 illustrate the elongate member manipulator in an openconfiguration. The elongate member manipulator 1800 includes the cover1801, a drive belt assembly 1810, an idler belt assembly 1820, and anelongate member support 1860. The cover 1801 is configured in threesections such that a middle section may hinge open to allow the elongatemember manipulator to open for loading and unloading of a guide wire1060 and valve assembly 1352 into and out of the elongate member support1860. The elongate member manipulator 1800 can be locked in a closedconfiguration by securing a locking knob 1813 into a locking knobthreaded hole 1815.

FIGS. 97B1-B2 illustrate different perspective views of the elongatemember manipulator 1800 with the cover 1801 removed. Several componentsincluding but not limited to the drive belt assembly 1810, the idlerbelt assembly 1820, an upper slide assembly 1834, a lower slide assembly1830, an insert motor 1802, a roll motor 1804, and the elongate membersupport 1860 are structurally and functionally similar to correspondingcomponents of the elongate member manipulators 1200, 1300 of FIGS. 9Band 15D-F previously described. Referring to FIG. 97B2 both the roll andinsert mechanism can be seen. FIG. 97B3 illustrates a zoomed in view ofthe roll motor and accompanying mechanisms with the manipulator mountingbracket (1858 shown in FIG. 97B2) hidden for clarity. The roll motor1804 directly drives a roll drive shaft 1806 which is coupled to a rollbelt 1808 which in turn drives a pinion 1838. As previously described indetail, the pinion 1838 drives a rack which controls linear movement ofthe upper slide assembly 1834 relative to the lower slide assembly 1830along linear bearings 1836. The belt drive assembly provides increasedtorque when actuating the upper slide assembly 1834. The drive beltassembly 1810 can be fixably coupled to the upper drive assembly 1834while the idler belt assembly 1820 can be fixably coupled to the lowerdrive assembly 1830. Thus linear movement between the drive and idlerbelt assemblies 1810, 1820 provide for roll of a guide wire held betweenthe belt assemblies 1834, 1820. Foot supports 1812 may be provided toprovide cantilever support of the belt assemblies 1810, 1820 as they aremounted to the upper and lower slide assemblies respectively 1834, 1830.The upper slide assembly 1834 may then be locked to the lower slideassembly 1830 in a closed configuration using the locking knob 1813which threads into the lower slide assembly 1830.

FIG. 97C illustrates the insert motor 1802 mounted to the upper slideassembly 1834 with the drive belt assembly 1810 installed. Othercomponents of the guide wire manipulator 1800 are hidden for clarity.The insert motor 1802 drives a set of helical gears 1803 that actuate aninsert shaft 1814. When the drive belt assembly 1810 is coupled to theupper slide assembly 1834, a drive shaft (not shown) is engaged with theinsert shaft 1814. As the insert shaft 1814 is actuated by the insertmotor 1802, the drive shaft actuates a drive belt 1818 in a mannerpreviously described in detail for the elongate member manipulator 1300shown in FIGS. 15A-D. The drive shaft 1816 can be seen in FIGS. 97D1-D3.FIG. 97D1 illustrates a perspective view of the drive belt assembly1810, FIG. 97D2 illustrates a cross sectional bottom view of the drivebelt assembly 1810, and FIG. 97D3 illustrates a zoomed in view of theend of the drive shaft 1816 which is coupled to the upper slide assembly1834. A drape which will be described in detail below can be installedbetween the drive and idler belt assemblies 1810, 1820 and the upper andlower slide assemblies 1834, 1830 respectively. The drape will provide asterile barrier between the mechanisms of the elongate membermanipulator 1800 and the belt assemblies 1810, 1820. In some situationsfluids, for example blood, saline, or water may flow onto the drape. Inorder to prevent fluid ingress into the mechanisms of the elongatemember manipulator through particularly the insert shaft 1814 shown inFIG. 97C,21C, a labyrinth seal 1817 may be provided. The labyrinth shapeof the drive shaft 1816 as shown in FIG. 97D3 in conjunction with thelabyrinth seal creates a winding path which fluid would need to passthrough before leaking into the insert shaft 1814. Additionally, thedrive shaft 1816 rests within a hole 1819 in the foot support 1812 whichmay be configured with a ring groove 1819 which can direct fluid away ordownwards prior to entering the labyrinth seal 1817.

In one variation, to accurately grip the guide wire between the beltassemblies 1810, 1820, the belt assemblies are configured such that theyare predominantly parallel with respect to one another. An adjustmentmechanism that provides for alignment of the drive belt assembly to theidler belt assembly is described with reference to FIGS. 97E1-G. FIGS.97E1-E2 illustrates the elongate member manipulator 1800 with severalcomponents hidden for clarity showing the upper and lower slideassemblies 1834, 1830 fixably coupled to the drive and idler beltassemblies (1810,1810, 1820) respectively. The drive belt assembly 1810can be fixably coupled to the upper drive assembly 1834 while the idlerbelt assembly 1820 can be fixably coupled to the lower drive assembly1830 using screw assemblies 1822 which are configured to thread intobelt assembly mounting holes 1824. Thus adjustment of the upper slideassembly 1834 relative to the lower slide assembly 1830 will result incorresponding adjustment of the drive belt assembly 1810 with respect tothe idler belt assembly 1820. While the lower slide assembly 1830 can bemounted stationary to the manipulator mounting bracket 1858 withoutadjustments, the upper slide assembly may be configured with adjustmentmechanisms which will now be described.

FIG. 97F illustrates a partially exploded view of the elongate membermanipulator (800)1800 of FIG. 97E with the drive and idler beltassemblies hidden for clarity. The upper slide assembly 1834 can includea top plate 1840 and a bottom plate 1842. The top plate 1840 whichincludes an alignment bar 1844 centered in a top plate opening 1841, anadjustment set screw 1847, an adjustment nut screw 1848 and anadjustment spring 1850 is illustrated exploded from the bottom plate1842 which includes a cradle 1846. When assembled, the cradle isconfigured to hold the alignment bar 1844 in a manner that allows thealignment bar 1844 to float in three separate axes of motion. FIG. 97Gillustrates a simplified representation of the alignment bar 1844 heldwithin the cradle 1846 showing top, front and side views. The alignmentbar 1844 can rotate about its own axis as shown with roll arrow 1852,translate up and down as shown with vertical arrow 1854, and also rotatein a rocking motion as shown with pitch arrow 1856. The alignment bar1844 is constrained in this configuration from rotating in a yaw motionor translating in a side to side direction. It is also constrained bythe fit of the cradle 1846 to the top slide plate opening 1841.

In this configuration, because the drive belt assembly 1810 is fixablymounted to the top plate 1840, as the top plate 1840 floats in a roll,vertical, or pitch direction, the drive belt assembly 1810 and top plate1840 float as a single component. The adjustment set screw 1847 can betightened or loosened to set the overall height of the top plate 1840and drive belt assembly 1810 relative to the idler belt assembly 1820.The adjustment not screw 1848 is tightened down increasing the downwardforce provided by the adjustment spring 1850 which presses the beltassemblies together. The adjustment set screw 1847 acts as a reaction orpivot point allowing the top plate 1840 to gimble about the roll andpitch axes of the alignment bar 1844. As the drive belt assembly 1810comes in contact with the idler belt assembly 1820, the latter of whichis stationary, the alignment bar 1844 provides the capability of selfparallel alignment between the two belt assemblies. The alignment nut istightened completely to secure the top plate 1840 to the bottom plate1842 such that the position of the drive belt assembly 1810 is securelyset.

FIGS. 97H1-H2 illustrate the elongate member manipulator 1800 with thedrive belt assembly and idler belt assembly removed showing the elongatemember support 1860 mounted to the manipulator mounting bracket 1858using a pair of mounting set screws 1866 which thread into membersupport mounting holes 1859. FIG. 97J1 illustrates the elongate membersupport 1860 with the valve assembly 1352 and guide wire 1060 installed.The elongate member support 1860 includes a support body 1862 and avalve holder 1864 which can be securably fixed to the support body 1862using screws 1863. FIG. 97J2 illustrates the elongate member support1860 in an open configuration allowing the valve assembly 1352 and guidewire 1060 to be removed. The valve assembly 1352 and guide wire 1060 canbe coupled as an assembly and can be removed and replaced into theelongate member manipulator 1800 with opening of the valve holder 1864and the opening of the drive belt assembly 1810 which hinges open aspreviously described. FIG. 97J3 illustrates the valve holder 1864 in aclosed configuration including a set of magnets 1870 are in the top andbottom portions of the valve holder 1864 which lock the valve holder1864 in a closed position. A stop 1869 can be provided to prevent thevalve holder 1864 from opening beyond a set rotation to preventcollision with any other components of the elongate member manipulator1800 or any other tools or instruments used during a surgical procedure.Magnets 1872 embedded in the stop and top portion of the valve holder1864 lock the valve holder 1864 in an open position as shown in FIG.97J4.

FIG. 97K1 illustrates a variation of a drape assembly 1900 that may beused to cover the elongate member manipulator and instrument driver. Aspreviously described, the drape assembly can be used to create a sterilebarrier between the instrument driver and non-sterile portions of theelongate member manipulator with the drive belt assembly, idler beltassembly, and guide wire. The drape assembly allows transfer ofmechanical motion from the instrument driver to each splayer as well asfrom the motors of the elongate member manipulator to the drive andidler belt assemblies. FIG. 97K2 illustrates a zoomed in view of thedrape assembly 1900 which can include a drape body 1901, sheath foam pad1902, a leader foam pad 1904, a tenting frame 1920, drape member supportholes 1936, and a locking knob hole 1938. The drape member support holes1936 and locking knob hole 1938 can be reinforced with frames that willprovide additional strength to prevent tearing of the drape when screwsare installed through the holes. The sheath and leader foam pads 1902,1902 were described previously in detail.

Referring to FIGS. 97L1-L2, the tenting frame 1920 is illustrated fromtop and bottom perspective views respectively showing flexure bases1922, flexures 1924, adhesive portions 1926, and reinforcement members1928. Each flexure base 1922 of the tenting frame 1920 can be fixableattached to the drape body 1901 with adhesive. The flexures 1924 of thetenting frame 1920 can adhere to the drape body 1901 along adhesiveportions 1926 of each flexure 1924 positioned along the centerline ofthe tenting frame 1920. The remaining length of each flexure 1924 can befree to move relative to the drape body 1901. The reinforcement members1928 can include drape idler belt mounting holes 1934, drape drive beltmounting holes 1930 and a drape drive shaft hole 1932. The reinforcementmembers 1928 are provided to reinforce the mounting holes 1930, 1934.The reinforcement members 1928 can be made from a material which istough enough to provide some strength where high forces will be imposedwhile also providing flexibility. Also it can be desirable for thereinforcement members 1928 to remain as thin as possible. If thereinforcement member 1928 are thick and compressible, as mounting screwsare tightened down the material is compressed. As the material settlesin the screws may require re-tightening which can be undesirable formid-procedure work flow. The reinforcement members 1928 can be made frompolycarbonate or any other type of plastic which fulfills the stiffness,thickness, and material strength requirements. Materials for othercomponents can include but not be limited to polyethelene for the drapebody 1901 and high-density polyethylene (HDPE) for the tenting frameflexure base 1922, flexures 1924, and reinforcement frames for the drapedrive shaft holes 1932, drape idler mounting holes 1934, drape membersupport holes 1936, and drape locking knob hole 1938.

FIG. 97M1 illustrates a simplified model of the elongate membermanipulator 1800. For clarity, only the model of the elongate membermanipulator 1800 and drape assembly 1900 are being shown. It should beunderstood that the elongate member manipulator 1800 may be installed onthe previously described instrument driver (1016 of FIG. 15A) and thedrape assembly 1900 can be configured to surround both the instrumentdriver and elongate member manipulator 1800. In order to install thedrape assembly 1900 to the elongate member manipulator 1800, the sterilecomponents including the drive and idler belt assemblies, the elongatemember support (1810, 1820, and 1860 respectively), and the locking knob1813 are removed from the elongate member manipulator 1800 as shown inFIG. 97M1.

Referring back to FIGS. 97A2, 97H2, 97K2, 97L1, 97E2 and to FIGS.97M2-M5, one variation of a method of installing a drape onto anelongate member manipulator 1800 can be seen. In this variation, thedrape member support holes 1936 are aligned with the member supportmounting holes 1859 and the elongate member support 1860 can beinstalled by securing the mounting set screws 1866 into the membersupport mounting holes 1859 as shown in FIG. 97M2. The drape idler beltmounting holes 1934 are aligned with the idler belt mounting holes 1824and the idler belt assembly 1820 is installed to the lower slideassembly 1830 by securing the idler screw assemblies 1822 into the idlerbelt mounting holes 1824 as shown in FIG. 97M3. The tenting frame 1920is folded over such that the drape drive belt mounting holes 1930 can besimilarly aligned with the drive belt assembly mounting holes 1825 andthe drive belt assembly 1810 can be installed by securing the drivescrew assemblies 1823 into the drive belt assembly mounting holes 1825in the upper slide assembly 1834 as shown in FIG. 97M4. The locking knob1813 is then fit through the drape locking knob hole 1938 and securedinto the locking knob thread hole 1815. The drape is held securely inplace between the sterile components including the elongate membersupport 1860, the idler and drive belt assemblies 1820, 1810, andlocking knob 1813 providing a sterile barrier between the sterilecomponents and the non-sterile components of the elongate membermanipulator 1800 and instrument driver.

During use, the locking knob 1813 can be loosened while being heldcaptive such that the elongate member manipulator 1800 can be opened inorder to load a guide wire 1060 as shown in FIG. 97A1-A2.21A1-A2. Thetenting frame 1920 is unfolded and stretched allowing the elongatemember manipulator to open while continuing to cover the non-sterilecomponents of the elongate member manipulator 1800. The guide wire 1060and valve assembly 1352 can then be loaded and the elongate membermanipulator 1800 can be closed for use including the rolling of theguide wire 1060 by translation of the upper and lower slide assemblies1834, 1830 as previously described. The tenting frame 1920 can servemultiple functions. It pushes the drape body 1901 in an outwarddirection so that the drape body 1901 is not pinched between the upperand lower slide assemblies 1834, 1830 as they are opened and closed.Also because the upper and lower slide assemblies 1834, 1830 translaterelative to each other during use, excess drape material must beprovided so that the drape body 1901 doesn't tear with this movement.Because the tenting frame 1920 is secured to the drape body 1901 onlyalong its centerline along the adhesive portions 1926, the tenting frame1920 shapes the drape body 1901 to manage the excess drape material.

FIGS. 98A-98B illustrate a different variation of an elongate membermanipulator 1400 mounted on the instrument driver 1016 using amanipulator mounting bracket 1058 such that a guide wire (not shown) canbe fed into the valve assembly 1352, then into the support tube 1056which subsequently feeds into a guide splayer 1052 or sheath splayer. Inalternative variations, the elongate member manipulator 1400 could bemounted on the instrument driver 1016 with a guide and/or a sheathsplayer assembly (e.g., the assembly 50/40 in FIG. 2), the elongatemember manipulator could be mounted with just a sheath assembly 1040 orthe elongate member manipulator 1400 could be mounted alone.

FIG. 99 illustrates the elongate member manipulator 1400 mounted to themanipulator mounting bracket 1058 with a guide wire 1060 loaded therein.FIGS. 100A-100B illustrates the elongate member manipulator 1400 withouta motor pack cover 1401 showing an insert motor 1402, a roll motor 1404and a belt assembly 1410. FIGS. 101A-101C illustrate a front and rearperspective view as well as a end view of the belt assembly 1410 whichincludes a drive belt 1412, an idler belt 1422, a drive pulley 1414,idler pulleys 1424, bevel gears 1416, a driving gear 1418, an idler gear1426, a driven gear 1420, and a clamp assembly 1440. The belt assembly1410 can be removably replaceable such that a sterile drape can beinserted between the belt assembly 1410 and the remaining drivecomponents, such that the belt assembly 1410 may be positioned in asterile field with the guide wire 1060.

To aid in loading the guide wire 1060 into the belt assembly 1410, theclamp assembly 1440 may be provided to open and close the belt assembly1410 as shown in FIGS. 102A and 102B. FIGS. 102A-102B each illustrate aside view of the drive assembly 1410 where FIG. 102A shows the beltdrive assembly in a closed configuration while FIG. 102B shows the beltdrive assembly in an open configuration. As seen best in FIGS.101B-101C, the clamp assembly 1326 includes a clamp 1442 that leversabout a pivot 1444 to open and close the idler belt 1412 portion of thebelt drive assembly in a clamping motion. A pair of clamp springs 1446can be used to provide the clamping force for closing the clamp assemblyin a nominally closed position. The clamp springs 1446 can be sized toprovide for enough clamp force to hold the drive and idler belts 1412,1422 together and effectively pinch the guide wire 1060 so it can besecured between the drive and idler belts 1412, 1422 while preventingdamage to the guide wire 1060. To load the guide wire 1060, the clamp1442 can be manually opened by compressing the springs 1446 while theguide wire may be back loaded through the belt drive assembly.

In order to actuate the belt assembly 1410, FIG. 100B and to FIG. 101Bshow the insert motor 1402 driving an insert belt 1406, turning aninsert shaft 1428, turning the driving gear 1418, the idler gear 1426and ultimately the driven gear 1420 which is coupled to a shaft drivingthe bevel gears 1416. The idler belt 1422 is free to rotate around thepassive idler pulleys 1424. As seen in FIG. 101A, the bevel gears drivethe drive pulley 1414 which turns the drive belt 1412 over idler pulleys1424. The drive belt 1412 and the idler belt 1422 are pressed togethercausing the idler belt 1422 to rotate in the opposite direction as thedrive belt 1412 and thus driving the guide wire 1060 pinched betweenboth belts in the insert or retract direction depending on the directionof the drive belt actuation. Referring back to FIG. 100B, roll actuationof the guide wire 1060 is illustrated. In order to roll the guide wire1060 the entire belt assembly 1410 is rolled on a roll shaft 1430. Theroll shaft 1430 is coupled to a roll belt 1408 driven by the roll motor1404.

FIG. 103 illustrates another variation of an elongate member manipulator1500 coupled to the instrument driver 1016 via a mounting bracket 1058positioned such that a guide wire (not shown) could feed through theelongate member manipulator 1500 and into a guide catheter splayer 1202and/or sheath splayer. In alternative variations, the elongate membermanipulator 1500 could be mounted on the instrument driver 1016 with aguide and/or a sheath splayer assembly (e.g., assembly 50/40 in FIG. 2),the elongate member manipulator could be mounted with just a sheathassembly 1040, or the elongate member manipulator 1400 could be mountedalone.

FIG. 104 shows the elongate member manipulator 1500 with its coverremoved, mounted to a manipulator base 1570 which in turn is mounted tothe manipulator mounting bracket 1058. The elongate member manipulator1500 includes an insert motor 1502, insert belt 1506, feed rollerassembly 1510, roll motor 1504, and roll belt 1508. The insert motor1502 and roll motor 1504 are each fixably mounted to the manipulatorbase 1570 and are coupled to an insert shaft 1528 and roll shaft 1530respectively.

FIG. 105 illustrates the feed roller assembly 1510 which includes theroll shaft 1530 and the insert shaft 1528. The insert motor 1502 drivesthe insert belt 1506, which rotates the insert shaft 1528 coupled to adrive gear 1518, which drives a driven gear 1520 which is coupled tobevel gears 1516, ultimately rotating a drive feed roller 1512, whichcan be positioned adjacent to an insert feed roller 1522. In onevariation, the insert feed roller 1522 could be passive such that whenthe drive feed roller 1512 is actuated in one rotational direction, thefrictional force between the drive feed roller 1512 and insert feedroller 1522 causes the insert feed roller to rotate in the oppositerotational direction. A guide wire (not shown) can be positioned betweenthe drive feed roller 1512 and insert feed roller 1522 such thatrotation of the feed rollers would result in a propelling actuation ofthe guide wire in the insert or retract directions depending on therotational direction of the feed rollers.

An alternative variation for actuation of the feed rollers isillustrated in FIG. 106A which is a zoomed in view of the feed rollerassembly 1510 with certain components hidden or shown as transparent forclarity. FIG. 106B is a top view of FIG. 106A. In this variation, theinsert feed roller 1522 is not passive but is driven at the same rate asdrive feed roller 1512 in an opposite rotational direction therebyinserting or retracting the guide wire 1060 held between the feedrollers.

FIG. 107A illustrates a top view of the feed roller assembly 1510 whileFIG. 107B illustrates a bottom view where certain components are shownas transparent for clarity. In this figure a feed roller gear train canbe seen which includes four gears with identical gear ratios including adrive gear 1514, a first idler gear 1515, a second idler gear 1517 and adriven gear 1519. By way of example but not limitation, each gear couldbe sized with a 48 pitch and 27 tooth count which could be coupled tofeed rollers that are ⅝″ in diameter. In alternative variations, thegears could be sized with varying pitch and tooth count and the feedroller may have varying diameters.

Drive gear 1514 is coupled to drive feed roller 1512 such that rotarymotion of drive feed roller 1512 actuates drive gear 1514 in aone-to-one rotary motion. Drive gear 1514 rotates first idler gear 1515which rotates second idler gear 1517, rotating driven gear 1519 which iscoupled to driven feed roller 1522 such that rotation of driven gear1519 actuates insert feed roller 1522 in a one-to-one rotary motion.Thus rotation of the drive feed roller 1512 via the gears, belts andmotors previously described rotates insert feed roller 1522 at the samerate in an opposite rotational direction. By way of example, when drivefeed roller 1512 is rotated in the clockwise direction, drive gear 1514is also rotated at the same rate in the clockwise direction. Drive gear1514 then drives first idler gear 1515 in the counterclockwisedirection, which drives second idler gear 1517 in the clockwisedirection, which drives driven gear 1519 in the counterclockwisedirection all at the same rotational rate if all gears have identicalgear ratios. Driven gear 1519 coupled to the idler feed roller 1414rotates idler feed roller in the counterclockwise direction resulting inopposite rotation of the drive feed roller 1512 and the driven feedroller 1522.

Roll of the guide wire may be actuated by rolling the feed rollerassembly 1510. Referring back to FIG. 104, the roll motor 1504 isillustrated actuating the roll belt 1508 which in turn rotates the rollshaft 1530 rolling a feed roller assembly 1510 and ultimately rollingthe guide wire (not shown) being held tightly between the feed rollers1512, 1522.

With elongate member manipulators 1400 and 1500, the insert belt 1406,1506 and roll belt 1408, 1508 are coupled to shafts 1428, 1528, 1430,1530 which are rotatably coupled to bearings so they are free to rotateindependently about the same axis of rotation. However, if either thebelt assembly 1410 or feed roller assembly 1510 is actuated to roll butthe insert belt 1406, 1506 remains stationary, the drive belt 1412 ordrive feed rollers 1512 will not remain stationary. Using the elongatemember manipulator 1400 from FIG. 100B as an example, if the beltassembly 1410 rolls by actuating the roll motor 1404 and the insertmotor 1402 remains off, the driving gear 1418 remains stationary whilethe idler gear 1426 circumvents the driving gear 1418 with the motion ofthe roll assembly 1402. Thus, the rotation of the idler gear 1426results in rotation of the driven gear 1420 and subsequent rotation ofthe bevel gears 1416 causing rotation of the drive belt 1412 andundesired insert of the guide wire 1060. The actuation of the insertmotor may match the actuation of the roll motor such that as the idlergear 1426 circumvents driving gear 1418 without rotating about its ownaxis. The rotation of the insert motor 1402 and roll motor 1404 may becoordinated to achieve the desired actuation.

In order to actuate the guide wire in the feed/insert/retract directiononly, the insert motor would be actuated while the roll motor wouldremain off. In order to roll the guide wire only withoutinsertion/retraction, the roll motor is turned and the insert motor isturned at an identical rate. In order to feed and roll the guide wiresimultaneously, the insert and roll motors may be actuated at differentrates. Because the current variation actuates roll by rolling the entirestructure, roll and insert of the guide wire can be simultaneouslyactuated without the effect of stripping or winding up the guide wire.The guide wire does not have to overcome any frictional holding effectsat the feed belts when being actuated in a roll direction since the feedbelts themselves are being rolled.

FIGS. 106A-107B show an example of a spring mechanism 1556 that canprovide for a constant force applied to the guide wire (not shown) bythe feed rollers 1512, 1522. The spring mechanism 1556 can provide forthe ability to grip variously sized guide wire diameters, and it canalso allow for top loading of the guide wire into the feed rollerassembly 1510. The spring mechanism 1556 can include a frame 1552, apivot frame 1554, a spring mount 1558, and a spring 1560. The frame 1552is shown in FIG. 106A as a solid case surrounding second idler gear1517, first idler gear 1515, and drive gear 1514. The frame 1552 remainsstationary relative to the insert shaft 1528 such that the only movementexperienced by the frame 1552 is rotation during roll of the feed rollerassembly 1510. The pivot frame 1554 is shown as a transparent case fitinto the frame 1552 but surrounding driven gear 1519, second idler gear1517 and the spring 1560 in a cup 1562. The spring mount 1558 is shownas a solid flange which holds one end of the spring 1560 in placeconstraining it within the cup 1562. The spring mount 1558 may beattached to the main plate 1452 using a pair of screws 1564, so that itis stationary to the frame 1552 (as best shown in FIG. 31B). The pivotframe 1554 is mounted such that it can rotate about second idler gear1517 but due to the spring force the pivot ram 1554 is held in anominally closed position pinching the feed rollers 1512, 1522 together.The spring 1560 can be sized to optimize the force necessary to hold aguide wire with enough friction to actuate it in the insert and rolldirections while not damaging the guide wire. By way of example but notlimitation, the pivot plate can be sized so that a swing arm allows a 2to 1 pinch advantage between feed rollers such that a 2.51b spring wouldresult in a 51b pinch force at the feed rollers. With a 2.51b spring,the range of guide wire diameters could be between about 0.014″ and0.038.″ In this example, a wire diameter smaller than about 0.014″ maynot be gripped adequately to provide insert and roll motion withoutslipping and a wire diameter above about 0.038″ may be damaged by thepinch force.

In one variation, the guide wire 1060 can be back loaded into theelongate member manipulator by manually loading the guide wire 1060 intothe proximal end of the feed roller assembly 1510, loading it into theproximal end of the roll shaft 1532 which could be provided with a thrulumen, and actuating the insert motor 1502 to actuate the feed rollers512, 522 in the insert direction until the desired length guide wire1060 is fed through the elongate member manipulator 1500. In analternative variation, the guide wire 1060 can be back loaded into theroll shaft 1530 as described above but then top loaded into the feedroller assembly 1510. To top load the guide wire 1060 the spring 1560could be compressed by manually squeezing the pivot frame 1554 towardsthe cup 1562 on the frame plate 1552, pivoting both the pivot plate 1554and idler feed roller 1522. FIGS. 108A and 108B show a representation ofthe bottom view of the gear train and feed rollers, and illustrate thespacing between the drive feed roller 1512 and the idler feed roller1522 created by squeezing the spring 1560 and pivot frame 1554. Theguide wire can then be loaded from above into a groove 1566 shown inFIGS. 106A, 106B, and 107A which helps center the guide wire between thefeed rollers 1512, 1522.

FIG. 109 illustrates a variation of a feed roller configuration that mayprevent or reduce slippage of the guide wire 1060 between the drive feedroller 1512 and the insert feed roller 1522 when insert or roll motionis actuated. In this variation, the drive feed roller 1512 is configuredwith a V-groove 1568 cut around its diameter. The guide wire 1060 mayfit in the V-groove 1568 and be held in position by the insert feedroller 1522. The guide wire 1060 may be held by three points of contact,two within the V-groove 1568 and one with the drive feed roller 1512without a groove thus constraining the guide wire 1060 vertically androtationally. In alternative variations, a similar groove may be cutinto the drive feed roller 1512 or it may be cut in the drive feedroller 1512 and not the insert feed roller 1522. The groove may be ofvarious dimensions depending on the range of wire diameter sizes and thenecessary contact between the groove and the guide wire. The groove mayalso be of various shapes including but not limited to semi-circular,square, or any polygon shape which could provide for necessary contactwith the guide wire.

Referring back to FIG. 107A, a guide wire groove 1566 is provided tohelp align the guide wire (not shown) vertically with the V-groove 1568in the drive feed roller 1412 as well as center the guide wire inbetween both feed rollers 1512, 1522.

As previously described, it can be desirable to maintain the guide wire1060 and a minimal number of disposable components in a sterile fieldand the remaining components in a non-sterile field. As shown in FIGS.110A-110B, in one variation, the feed roller assembly 1510 could beseparated into two sub-assemblies, an insert assembly 1511 which ismaintained in the sterile field and an actuation assembly 1513positioned in the non sterile field. The insert assembly 1511 couldinclude the gears and rollers provided for insertion of the guide wireincluding but not limited to the spring mechanism 1556, gears (1514,1515, 1517, 1519), rollers 1512, 1522, driven gear 1520, and bevel gears1516. The actuation assembly 1513 could include the driving gear 1518,insert shaft 1528, and roll shaft 1530. While the actuation assembly1513 still includes a number of gears and pulleys, a number of expensivecomponents including gears, the insert and roll motors 1502, 1504,insert and roll belts 1506, 1508, and instrument driver 1016 wouldremain in the non-sterile field.

FIGS. 109-110 also show one way to mount the insert assembly 1511 to theactuation assembly 1513 allowing for separation of sterile versusnon-sterile components where the insert assembly 1511 could beremoveably coupled to the actuation assembly 1513 which is fixablymounted to the other components of the elongate member manipulator 1500.A sterile drape (not shown) could be positioned between the insertassembly 1511 and the non-sterile components. Referring to FIG. 110 aswell as back to FIG. 108, the insert assembly 1511 could be mounted to amounting plate 1572 using mounting screws 1574. The mounting plate 1570could be fixably mounted to a manipulator base 1570 which provides thebase structure for the insert motor 1502, the roll motor 1504 and thefeed roller assembly 1510. In alternative variations, an interface thatallows for quick removal and replacement of the insert assembly 1511without the use of tools could be used. Additionally the interface couldinclude mating components on the sterile drape.

It should be understood that any of the previously described elongatemember manipulators could include multiple variations of feed rollerand/or feed belt combinations. FIGS. 111A-111D illustrate examples ofsuch combinations. FIG. 111A illustrates a variation using multiple feedroller pairs 1710, 1712 a, 1712 b, 1712 c for actuating the guide wire1060 where motor driven feed roller pair 1710 drives the guide wire 1060in an insert motion while feed roller pairs 1712 a, 1712 b, 1712 c canbe idler rollers which are free to rotate. FIG. 111B illustrates avariation using multiple feed belt pairs 1720, 1722 a, 1722 b foractuating the guide wire 1060 in an insert motion where feed belt pair1720 is motor driven and feed belt pairs 1722 a, 1722 b are idler beltswhich are free to rotate. FIG. 111C illustrates a variation that uses acombination of feed roller pairs and feed belt pairs where feed rollerpair 1714 is motor driven while feed roller pair 1716 and feed beltpairs 1724 a, 1724 b are idle and free to rotate. Alternatively feedbelt pair 1724 a can be motor actuated while feed belt pair 1724 b andfeed roller pairs 1714, 1716 are idle as shown in FIG. 111D. FIGS. 111Eand 111F illustrate alternative variations which feed rollers and feedbelts are not used in pairs but a single set of feed rollers 1718 a,1718 b, 1718 c and a feed belt 1726 are used to grip the guide wire1060. FIG. 111E illustrates a variation in which the feed roller 1718 ais motor driven to actuate the guide wire 1060 while FIG. 111Fillustrates the feed belt 1726 as motor driven.

It should be understood that alternatively any of the idle roller pairsand idle belt pairs could be motor driven, any motor driven feed rollerpairs and feed belt pairs could be idle, and while a specific number ofpairs of rollers and/or belts are illustrated, any number can be used.Additionally in any pair of feed rollers or feed belts, one feed rolleror feed belt could be motor driven while the other could be idle. In theconfiguration illustrated in FIGS. 111C and 111D, any combination offeed roller pairs and feed belt pairs could be used in any order andfurthermore any combination of feed rollers, feed roller pairs, feedbelts and feed belt pairs from any of the variations previouslydescribed may be used. Motor driven actuation can be provided in themanner previously described and roll actuation of the guide wire can beprovided with the translation of the feed rollers/feed belts along theirown axes of rotation also previously described.

FIGS. 124A-C illustrate another alternative variation of an elongatemember manipulator 1600. FIG. 124A illustrates the elongate membermanipulator 1600 with a manipulator cover 1601 installed while FIG. 124Billustrates the manipulator cover 1601 removed. The elongate membermanipulator 1600 includes a member holder 1608, an insertion drive 1610,and a rotation drive 1620 each of which can be directly or indirectlymounted to a manipulator base 1606. FIG. 124C shows the insertion drive1610 which includes an insert motor 1602, a leadscrew 1612, a leadscrewnut 1614, and/or a linear slide 1616.

FIGS. 125A-C illustrate a perspective, side, and zoomed in views of therotation drive 1620 respectively which includes a rotation base 1618, arotation drive bracket 1622, roll motor 1604, a drive gear 1624, arotation gear 1626, a collet 1628, a collet solenoid 1632, and/or acollet mount 1634. The collet 1628 can be coupled to the collet mount1634 using collet bearings 1636 such that the collet 1628 can be free torotate within the collet mount 1634. The collet 1628 may also be coupledor fixably coupled to the rotation gear 1626 such that actuation of therotation gear 1626 would drive rotation of the collet 1628.

FIG. 125B illustrates the rotational drive 1620 with the guide wire 1060loaded. It should be understood as described previously that the guidewire 1060 is shown for illustrative purposes and any type of elongatemember may be loaded into the manipulator 1600. In order to load theguide wire 1060 into the system, the collet 1628 can be opened, theguide wire 1060 can be backloaded into the system, and the collet 1628can then be closed gripping the guide wire 1060. The collet 1628functions as a typical chuck or collet chuck as is well known in the artsuch that in order to loosen or tighten the collet 1628, one end of thecollet 1628 would be held stationary while the other end is rotated.Depending on the direction of rotation, the collet is either tightenedaround the guide wire 1060 or loosened from the guide wire 1060. In thisvariation, the opening and closing of the collet 1628 can beautomatically or remotely controlled. The collet 1628 can be geared suchthat collet teeth 1630 can mate with the collet solenoid 1632. When thecollet solenoid 1632 is activated to engage one end of the collet 1628is held stationary, the roll motor 1604 can turn the drive gear 1624,which will rotate the rotation gear 1626, rotating the other end of thecollet 1628 which will loosen or tighten the collet 1628 depending onthe direction of rotation.

Once the collet 1628 is closed adequately holding the guide wire 1060,the collet solenoid 1632 can be disengaged from the collet teeth 1630.In this configuration, rotation of the rotation gear 1626 which isindirectly driven by the roll motor 1604 will not cause the collet 1628to loosen or tighten. Instead, the entire collet 1628 will rotate withthe rotation gear 1626 thus rolling the guide wire 1060 which is heldsecurely in the collet 1628.

In order to actuate the guide wire 1060 in the propelling motion,inserting or retracting it axially, the rotation drive 1620 can bemounted to linear slide 1616 as shown in FIG. 124C. The leadscrew nut1614 can be fixably mounted to the rotation base 1618 and coupled to theleadscrew 1612 such that when the insert motor 1602 drives the leadscrew1612, rotation drive 1620 is controllably driven linearly and the guidewire 1060 can be controllably propelled in the insert or retractdirection depending on the rotational direction of the insert motor1602.

In one variation, the insert/retract stroke can be limited by thephysical travel of the linear slide 1616. In an alternative variation,an infinite insert or retract distance may be achieved.

FIG. 126 shows a side cross sectional view of the elongate membermanipulator 1600 illustrating the member holder 1608 which can include aholder solenoid 1638. The holder solenoid 1638 can include a holder tip1640 that is actuated to hold or release the guide wire 1060. When theguide wire 1060 is being actuated in the roll or propelling directions,the holder solenoid 1638 can be actuated to release the guide wire 1060to move freely through the member holder 1608. When the linear slide1616 has reached its forward limit in the propelling direction, theholder solenoid 1638 can be actuated to hold the guide wire 1060 in themember holder 1608, the collet 1628 can be actuated to open, releasingits grip on the guide wire 1060, and the rotational drive 1620 can betranslated back to the reverse limit of the linear slide 1616. Thecollet 1628 can then be actuated to tighten around the guide wire 1060,the holder solenoid 1638 can be actuated to release the guide wire 1060within the holder member 1608, and the guide wire 1060 can again beactuated in the propelling and roll directions in the manner previouslydescribed. The same method can be used in the retract direction.

In one variation, algorithms for control of the elongate membermanipulator 1600 can be applied such that the sequence of collet andholder solenoids 1632, 1638 as well as insert and roll motors 1602, 1604are coordinated to create rapid and seamless actuation of the elongatemember manipulator 1600. Additionally algorithms can be implemented thatwill control the opening and closing of the collet 1628 based on thesize of the guide wire 1060, catheter or any other type of elongatemember that would be loaded into the elongate member manipulator 1600. Alookup table of rotations based on type of guide wire or elongate membercould be programmed into the system controller and the user could inputthe information regarding the type of elongate member into the systembefore use. The look up table could be created using empirical data orcalculations based on known mechanical properties of the elongatemember. Alternatively, closing and opening of the collet could be basedon sensed force during of rotation of the rotation gear 1626. When thecollet solenoid 1632 is actuated to hold the collet teeth 1630 and thecollet 1626 is being actuated to close using the rotation gear 1626,sensing the force imparted on the gear during rotation could be anindicator of when to cease rotation as the collet 1626 closes around theguide wire 1060. Mechanisms for sensing force will be described infurther detail below.

For certain variations of the elongate member manipulator, it can bedesirable to provide the capability of measuring the external forceapplied to the distal end of the elongate member, e.g., a guide wire.Thus, if the distal tip of the guide wire makes contact with tissue, theuser could be aware of the force being applied to the tissue. Theelongate member manipulator 1600 illustrated in FIGS. 124A-C can includea variation of force sensing that provides for force sensing duringinsert/retract and roll actuation of the guide wire 1060.

FIG. 127A illustrates the rotation drive 1620 for the elongate membermanipulator 1600 and FIG. 127B illustrates a side cross sectional sideview of rotation drive 1620 displaying a load cell 1642 mountedstationary relative to the rotation base 1618 and a fulcrum 1644 whichallows the lower portion of the rotation drive bracket 1622 to pivottowards or away from the load cell 1642. Thus any forces experienced bythe guide wire 1060 which is held securely in the collet 1628, willcause the rotation drive bracket 1622 to transmit forces to the loadcell 1642. With known kinematics and base-lining of initial load cellreadings, force applied to the distal tip of the guide wire may becalculated.

FIG. 127C illustrates a side view of the rotation drive 1620 with a backcross sectional view of the rotation drive 1620. In this variation, theroll motor 1604 is mounted to a motor bracket 1646 which is supported ona set of bearings 1648 which constrain the bracket 1646 in a fixedvertical and horizontal position yet allow the bracket 1646 to rotateabout the roll motor rotational axis as illustrated by the arrows 1652.The bracket 1646 can include a lever 1654 which can be positionedagainst an LVDT sensor 1656 that can be fixably mounted to the rotationdrive bracket 1622. Thus a reactive torque imparted on the motor 1604 inthe rotational direction would be transmitted to the LVDT 1654 and couldbe read as resistive force experienced by the guide wire 1060 during aroll actuation. In order to prevent damage to the LVDT 1654, hard stops1650 could be mounted to the rotation drive bracket 1622.

FIG. 112A illustrates a variation of an apparatus that provides forcemeasurement of a guide wire distal tip during insert. FIG. 112A shows abottom perspective view of the elongate member manipulator 1200. Itshould be understood that the elongate member manipulator 1200 is shownby way of example, and this force sensing apparatus could be used forany of the elongate member manipulators described herein. The lowerslide assembly 1230 is mounted to the manipulator mounting bracket 1058to which a strain gauge 1080 is also mounted. When force is applied tothe distal tip of the guide wire 1060, the lower slide assembly 1230mounted to the manipulator mounting bracket 1058 is displaced causing areading in the strain gauge 1080. The strain reading can be used tocalculate a guide wire distal tip force.

An alternative variation of a force measurement apparatus is illustratedin FIG. 112B. In this variation, the elongate member manipulator 1500 isshown with a strain gauge load cell 1082 fixably mounted to themanipulator base 1570. The manipulator base 1570 is mounted to themanipulator mounting bracket 1058 using a pair of linear slides 1084which allow movement of the manipulator base 1570 and thus the elongatemember manipulator 1500 in the insert/retract direction or the directionalong the axis of the guide wire (not shown in FIG. 112B). A forcesensing block 1086 is fixably mounted to the manipulator mountingbracket 1058 but is positioned so that it fits between the arms of theload cell 1082. When an external force is applied to the distal tip ofthe guide wire (not shown), the elongate member manipulator 1500 ismoved back in the retract direction along with the manipulator base 1570via the linear slides 1084. The load cell 1082 is also pushed in theretract direction making contact with the force sensing block 1086resulting in a force reading from the load cell 1082.

Strain gauges or load cells mounted to the manipulator base 1470, 1570or bottom of the elongate member manipulator 1200, 1300 may be used tosense distal tip force for any of the variations of elongate membermanipulators described previously in a manner described above. However,other types of sensors mounted to either the distal tip of the elongatemember or on the proximal end of the elongate member on the elongatemember manipulator may be used to detect distal tip force including butnot limited to strain gauges, piezoelectric sensors, tactile sensors,and quartz force sensors. Alternatively, sensors can be used to detect achange in length of the elongate member which measurement can be used incombination with known mechanical properties to calculate force.Examples of such sensors include but are not limited to a fibers,optical sensors, electromagnetic sensors, inductive sensors, capacitivesensors, vision systems etc.

The elongate member manipulators described herein may be mounted to anytype of structure depending on the desired use and any environmentalconstraints. In one variation, the elongate member manipulator may bemounted to a stationary arm mounted to a bedside rail of a patient bed.In alternative variations, the elongate member manipulator could bemounted to a bedside cart. In the variation shown back in FIG. 83A, theelongate member manipulator 1200 is mounted directly to the manipulatormounting bracket 1058, which is fixably mounted to the instrument driver1016. The elongate member manipulator 1300 could be mounted in a similarfashion. FIGS. 98B and 103 show the elongate member manipulator (1400and 1500 respectively) each including a manipulator base 1470, 1570which is fixably mounted to the manipulator mounting bracket 1058, whichis fixably mounted to the instrument driver 1016. The various mountingmechanisms for mounting the instrument driver to a bedside rail or cartwere described previously.

One example of a mechanism for mounting the manipulator mounting bracket1058 to the instrument driver 1200 is best shown in FIG. 103. Though theelongate member manipulator 1500 is shown in this figure, it should beunderstood that any of the elongate member manipulators described hereincan be mounted in the same manner using the same apparatus. In thisvariation, a vise clamp 1062, such as one found from CarrLane TinyVise™, which provides a clamp as well as a captured hex screw, can beused to fixably attach the manipulator mounting bracket 1058 to a tappedhole 1064 on the instrument driver 1200. The vise clamp 1062 providesenough clamping force as well as thrust force to securely attach themounting bracket 1058 to the instrument driver 1200 while preventing themounting bracket 1058 from lifting away from the instrument driver 1200due to the weight of the elongate member manipulator 1500. In analternative variation an adapted vise clamp 1063 may be altered tochamfer the edges 1065 of the vise clamp as shown in FIGS. 103AA and103AB. The adapted vise clamp 1063 can be coupled with a mating bracket(not shown) so that as the adapted vice clamp 1063 is tightened, itexpands within the bracket locking it into place as shown with thearrows 1067. In one variation, a sterile drape (not shown) may be placedbetween the adapted vise clamp 1063 and the mating bracket (not shown)allowing a separation between sterile and non-sterile components withoutpuncturing the sterile drape, preventing any breakage of the sterilebarrier.

In alternative variations, a plurality of different types of mountingscrews, bolts, or any fastener sized properly to obtain the desiredclamping force could be used in place of the vice clamp 1062 while themounting bracket 1058 can be dimensioned at a thickness that couldprevent lifting due to elongate member manipulator 1400 weight or due tothe weight of any of the various elongate manipulators described herein.

FIGS. 103A-B illustrate variations of a roll support 1580, 1582.Depending on the size and type of elongate member or guide wire beingused, it may be difficult to provide enough torque at the proximal endof a guide wire or elongate member to accurately roll the distalsection. The roll support tube 1580,1582 can provide any number ofopposing bends necessary, creating a wave with varying pitch andamplitude between successive bends. In one variation, the roll supportmay be adjustable such that the number of bends can be altered dependingon required torque.

Referring to FIG. 103A, the elongate member manipulator 1500 is shownwith the roll support tube 1580. The roll support tube 1580 may beconfigured to receive the guide wire 1060 or various sizes and types ofguide wires co-axially, and can be provided proximally adjacent to theelongate member manipulator 1500. The roll support tube 1580 providesrigid curves which place the guide wire 1060 in several bends. As theguide wire 1060 is actuated in roll, the roll support tube 1580 remainsin the curved configuration but rotates about the longitudinal axis ofthe guide wire 1060. The bends prevent the wire from rolling within theroll support tube, minimizing or eliminating uncontrolled wind up of theguide wire within the support tube or guide catheter. Thus the rollsupport tube 1580 assists in providing the torque necessary to gainaccurate roll control of the wire through the guide catheter (not shown)or support tube (not shown) provided at the distal end of the elongatemember manipulator 1500. In alternative variations, the roll supporttube 1580 could be manufactured from a semi-flexible material whichprovides rigid support during roll actuation. The roll support tube 1580can be hand molded to provide the necessary bend configuration.

FIG. 103B illustrates an alternative variation of a roll support tube1582 which provides bends of variable pitch and amplitude. Because theroll controllability of the guide wire is dependent on the size andmaterial of the wire itself, different wires may require sharper bendsin order to gain accurate controllability while bends that are too sharpfor some types of wires may cause damage to the wire. Thus a scissorjack support 1582 can be used to provide the bends necessary to providetorque control in an adjustable manner for various types of wire. Thescissor jack support 1582 may provide torqueability support in the samemanner as the roll support tube 1582 and provides for an adjustabilityof curve amplitude and pitch.

Referring back to FIG. 1, an operator 12 is shown at an operatorworkstation 22 which provides remote control of a guide catheter 1054,sheath catheter 1044, and elongate member manipulator. Details regardingthe control of the sheath catheter, guide catheter, and instrumentdriver are provided in the aforementioned incorporated references.Control of an elongate member manipulator can be approached in a mannersimilar to the way any remotely controlled robotic master slave systemwould be controlled according to the references incorporated herein oras is well known in the art. The elongate member manipulator systems ofany of the previously described variations will be described hereinwhere the master would be an input device such as the operatorworkstation 22 and the slave would be any of the elongate membermanipulators (1100, 1200, 1300, 1400 or 1500). The elongate membermanipulator fundamentally has two degrees of freedom, roll and insert,that could be controlled with a single master with two degrees offreedom, or by two separate master devices that each control one degreeof freedom. The following provides various masters that provide inputfor these degrees of freedom. In other variations, the manipulator canprovide one or more degrees of freedom controlled by one or moremasters.

Referring back to FIG. 2, an example of an operator workstation 22providing for inputs for control of the guide catheter, sheath catheterand elongate member manipulator is illustrated. As previously describedthe operator workstation 22 includes the master input device 1212 actingas a joystick type controller along with the pendant 8 acting as akeyboard type input device. In one variation, the guide catheter iscontrolled using the master input device 1212 allowing for steering ofthe distal tip of the guide catheter as viewed on the display monitors44 while the sheath catheter and the guide wire are controlled using thependant 8. As previously described in detail, the master input device1212 includes several sensors which detect the position of the masterinput device 1212 shown in this variation as a joystick. Those sensorssend signals to the controller that are interpreted as commands.

FIG. 113 illustrates a variation of the pendant 8 of FIG. 2 which wouldinclude controls for the sheath catheter and elongate membermanipulator. In order to steer the sheath catheter, the bend, insert androtate controls 1026 located on the right side of the pendant 8 could beused while the rotate and insert controls 1028 located on the lower leftside of the pendant 8 could be used to control the elongate membermanipulator. In alternative variations, the distal tip of the guide wirecould be controlled using the master input device 6 while the guide andsheath catheters are controlled by the control console 8 or the sheathcatheter could be controlled by the master input device 6. In fact anycombination of controls could be implemented using either or both thecontrol console 8 and/or the master input device 6.

The display and force sensing controls 1030 located on the upper left ofthe control console 8 could be used to control the views on the monitorsand activate and control force sensing capabilities respectively and thetrackball controls 1032 could be used to control cursors on the display.As described in detail in the aforementioned incorporated references,the display could show images of patient anatomy in the form of modelsor fluoroscopic images. Cartoon images of the guide, sheath, and guidewire within the patient anatomy can be displayed showing commandedpositions. Actual images of the guide, sheath, and guide wire can beshown from fluoroscopic data. Additionally the display can also showforce feedback readings

In an alternative variation, it could be desirable for the controls tobe located closer to the patient bed. Referring to FIG. 114A, avariation of the patient bed 1020 is shown with a standalone console1024 mounted to the bedside rail 1021 such that the operator couldcontrol the system from beside the bed. FIG. 114B illustrates a sideview of the standalone console 1024 mounted to the bedside rail 1021where the patient bed 1020 is not shown for clarity. The standaloneconsole 1024 can rest on a mounting tray 1036 that is fixably attachedto the bedside rail 1021 via a clamp 1038. FIG. 115 illustrates oneexample of standalone console 1024 which eliminates some components fromthe control console 1008 and retains the controls for the sheathcatheter 1026 and the elongate member manipulator 1028. In alternativevariations, the standalone console 1024 could be used in conjunctionwith the control console 1008 with two operators working together inwhich case one console could override controls if conflicting commandsare sent from each console of another depending on configuration.

Alternatively, several other types of input devices could be used toprovide the signals for the one or more degrees of freedom necessary tocontrol the elongate member manipulator. In the case where either theelongate member manipulator is mounted to a setup structure alone ormounted on the instrument driver, but control of only the elongatemember manipulator is necessary, other types of input devices may beused.

FIGS. 116-116N illustrate various master input devices that could beused in place of a joystick controller and/or console.

FIG. 116 illustrates an alternative variation of a master input device.As is well known the art, manual control of guide wires typicallyincludes a two handed sequence to propel a guide wire in the insert orretract directions. Typically the guide wire is coupled to an introducerthat can be used as a handle for an operator. The operator will advancethe guide wire, by using a front hand to support the introducer and therear hand to grip the guide wire pushing it through the introducer. Thisonly accounts for advancement of the guide wire a short distance so thefront hand may release the introducer, grip the guide wire, allowing therear hand to release the guide wire in order to grip it a short distancefurther back along the guide wire. The front hand can now release theguide wire to allow the rear hand to advance the wire. This is repeateduntil the guide wire is advanced to the desired position typicallyadvancing the wire 1″ to 2″ at a time. In many cases, the total insertdistance can be as far as 2 meters. The wire can be rotated manuallyusing one or both hands to rotate the wire while inserting it.

The master input device shown in FIG. 116 stimulates the motionphysicians are accustomed to during manual procedures while eliminatingthe need for multiple two handed iterations necessary for manual insert.The master input device 1660 can include an insert motor 1662, a rollmotor 1664, a flexible member 1666, a handle (not shown), a linear slide1668, actuation cables 1670, pulleys 1672, and/or a support 1674. Thehandle (not shown) is coupled to the flexible member 1666, which in turnis coupled to the roll motor 1604, which is fixably mounted to thesupport 1674, mounted to the linear slide 1668. Using the pulleys 1672and actuation cables 1670 the linear slide 1668 is coupled to the insertmotor 1602. A variety of motors may be utilized, e.g., the motors can be13 mm DC brush servo motors and the handle can include a grasper button(not shown). The support 1674 can be made from a lightweight material,such as a lightweight plastic and the linear slide 1668 can also belightweight and low friction.

During operation, the user depresses the grasper button and rotates thehandle (not shown). The roll motor 1604 which is equipped with anencoder reads the rotation of the handle and transmits this data to thecontroller which will control the roll of the elongate membermanipulator. In order to control insert, the user depresses the grasperbutton, moves the handle forwards or backwards along the linear slide1668, while the insert motor 1602 encoder reads the rotation of themotor 1602 and thus the linear movement of the handle. This data isagain transmitted to the controller. When the user has reached thephysical limit of the linear slide 1668, the grasper button is releasedand the user may slide the handle to a nominal linear position withoutsending a signal to the controller indicating desired propellingactuation of the elongate member manipulator.

FIG. 117A illustrates a master input device based on a slider that canbe moved on a fixed rod. When the engage button is pressed thetranslation and rotation of the slider are measured by sensors and usedto command the insert and rotation of the guide wire. When the engagebutton is released, the slider can be moved freely or alternatively canbe spring loaded to return to a fixed position. The slider can bemounted to a handle as shown in FIG. 117AA.

FIG. 117B illustrates a paddle switch that could be mounted to theinstrument driver 1016 which could control insert, or retract, and/orroll of the guide wire. The paddle switch can be provided with recessedcontact switches as shown in FIG. 117BB that may be pressed to enablethe paddle switch. Alternatively the paddle switch can be pinched fromboth sides as shown in FIG. 117BBB to activate it. FIG. 117C illustratesscroll-wheels that can be incorporated into the handle of a master inputdevice. Each scroll-wheel could be used to control a different degree offreedom on the elongate member manipulator. Alternatively FIG. 117CCshows buttons incorporated on the master input device handle that couldcontrol different degrees of freedom on the elongate member manipulatormeasuring force applied to each button to determine control of themanipulator. FIG. 117D shows a wheel with a circular cross-sectionedrim. By hiding most of the wheel inside of a housing or below the tablesurface, the user is presented with a rail that can be moved in aquasi-linear fashion by rolling the wheel. This gives an infinite rangeof travel device that could be used to control insert of the guide wire.The wheel could be tilted to either side to control roll of the guidewire.

FIG. 117DD shows another variation where the rail itself is constructedout a series of rollers so that it can be spun to control the roll ofthe guide wire. FIG. 117E shows a control plate mounted to a 2-DOF(pitch-roll) rotation platform. This control plate could be manipulatedby the physician with either their hand or foot providing pitch motionto control insert or retraction and rolling motion to control guide wireroll. FIGS. 117F and 117FF show linear sliders (with an optional engagebutton) that can be used to control one DOF of the elongate membermanipulator. FIG. 117G shows a touchpad device that could be used tocontrol the guide wire manipulator. Moving the user's fingerforwards/backwards would control insertion of the guide wire and movingthe user's finger side-to-side would control roll of the guide wiremanipulator. Alternatively a trackball could be used in a similarfashion (not shown). FIG. 117H shows a “clothes-line” type configurationof a wire or cable looped around several pulleys. The user coulddirectly insert, retract and/or roll this wire by hand or through theuse of an optional wire torque device to allow for easier gripping ofthe wire. FIG. 117I shows a wide variety of buttons that could be usedalone or in combination to control the guide wire manipulation device.Various methods of use of such buttons will be described in detaillater. FIG. 117J shows a wrist-mounted master input device. FIG. 117Kshows a hand-held inertial master input device. FIG. 117L shows a masterinput device that is manipulated by inserting, retractiong and/orrolling the operator's finger. FIG. 117M shows a haptic feedback master.The user manipulates the master by inserting, retracting and/or rollingit. The master is mounted to a compartment that contains sensors andmotors. The master could be free to slide, spring loaded, or fixed. Theactive master may sense input and provide feedback to the user viamotors under servo control.

The input devices may measure a signal from the operator and map thissignal into a command to the slave such as the elongate membermanipulator. Input devices on the master side may measure variousdifferent types of signals including but not limited to force, position,velocity, acceleration, or discrete events such as buttons presses.These measured signals could be converted into commands in the form offorce, position, velocity, acceleration, or a higher level task. A fewcombinations of various input signals to commands will be discussedfurther using the elongate member manipulator as the slave however itshould be understood that these variations will be presented by way ofexample and not limitation. Any combination of the aforementionedsignals and commands could be implemented including types of comparablesignals and commands that are not explicitly mentioned but are wellknown in the art. Additionally, any slave mechanism could be commandedincluding but not limited to the mechanisms actuating the guidecatheter, sheath catheter, and instrument driver.

FIG. 118a-d illustrates flow diagrams of the various master-slavecontrol mapping options. FIG. 118a illustrates one variation where aposition signal is measured from the input master device and a positioncommand is sent to the slave. Motions of the master are translated intomotion commands and sent to the slave in a one to one motion in onevariation while in an alternative variation the motion command could besubject to a scaling factor or more complex mapping function in a mannerdescribed in detail in the aforementioned incorporated references. Insome instances the elongate member manipulator has a very large range ofmotion which may require either the input device to have a comparablylarge workspace or the input device to have clutching capabilityallowing it to clutch to different portions of the of the slaveworkspace. In an alternative variation shown in FIGS. 118b and 118d , aposition signal is measured from the input master device and a velocitycommand is sent to the slave. This typically involves a master devicethat is spring-loaded to return to its zero position such that when theuser releases, the master returns to zero and the slave stops moving.This approach has the advantage of using a master with a relativelysmall range of motion to control a very large (up to infinite) range ofmotion on the slave. In FIG. 118b the slave is controlled using velocitycommands while in FIG. 118d the slave is controlled using positioncommands. FIG. 118d further illustrates a variation where positionsensors on the guide wire manipulator itself are used for closed loopiterative control of the guide wire manipulator in order to moreaccurately position the guide wire manipulator. In yet another variationshown in FIG. 118c , a force signal is measured from the input masterdevice and a velocity command is sent to the slave such that a higherforce measurement will result in an increased velocity of the slave.Using a device such as the buttons on the MID handle as illustrated inFIG. 117CC for example, the harder the operator pushes on the button,the faster the elongate member manipulator inserts/rolls. When theoperator is not exerting any force, the slave remains still. Thisconfiguration allows for a master with a small (near zero) range ofmotion to control a very large (up to infinite) range of motion on theslave. In further variations, multiple types of input signals can becombined so that arbitrarily complex dynamics between the master andslave can be introduced.

Another configuration may use discrete events such as but not limited toa button press or activation of a switch as an input to the mastersending a specified task to the slave. Various types of buttons may beused, as illustrated in FIG. 117J. In this configuration, a button pressof one or several different buttons can be used to command the executionof a potentially complex task. In one example for one degree of freedom,holding down of a single first button may cause a motion in apre-defined direction at a pre-defined speed and release of the buttonwould cease motion. A second button could be used in same manner tocause motion in an opposite direction at the same pre-defined speed.Using the elongate member manipulator as an example, holding down thefirst button may cause the elongate member to be inserted at a set speeduntil the user releases the button. Holding down the second button maycause the elongate member to be retracted at the same speed until thebutton is released. A second pair of buttons could be used for roll inthe clockwise and counterclockwise directions. Alternatively, the sameconfiguration could be used where a first single button push may startmotion and a second push may stop motion or one button could startmotion and a second button could stop motion. In another variation, abutton push could cause the elongate member manipulator to move in apre-determined direction, by a pre-determined amount, at apre-determined speed. The predetermined amount could be a set distanceor a distance based on a relative position of the elongate member, forexample, distance from the elongate member to tissue or distance to theend of a guide catheter if the elongate member was traveling co-axiallydown the lumen of said guide catheter. Alternatively, the speed could bebased on the duration of time a button is pushed such that as the buttonis held longer, the speed gradually increases or after being pushed fora fixed duration of time, the speed increases from one predeterminedamount to another. Alternatively, the movement could be based on apre-determined force, for example the elongate member may insert untilit makes contact with an object and a pre-set threshold of distal tipforce is reached.

Multiple combinations of buttons, switches, and other types of on/offinput devices could be used with multiple combinations of elongatemember movement. It should be understood that the aforementionedcombinations are by way of example and not limitation and anycombination of inputs to motion including equivalents well known in theart may be used.

In the variation shown in FIGS. 1-2 which includes the operatorworkstation 22, the controller 55, and the instrument driver 16, theoperator workstation includes the input controls in the form of ajoystick type master input device 1212 and pendant 8. This variation maybe used in a configuration shown in FIG. 119 which displays the sheathcatheter assembly 1040, the guide catheter assembly 1050, and theelongate member manipulator 1300 mounted to the instrument driver 1016with an elongate member in the form of a guide wire 1060 loaded in theelongate member manipulator 1300. The guide wire 1060 is sized to beinserted co-axially into the lumen of the guide catheter 1054, which inturn is sized to be inserted co-axially into the lumen of the sheathcatheter 1044.

As previously described, the two degrees by which an elongate member,such as a guide wire 1060 may be manipulated using the elongate membermanipulator 1300 are insertion/retraction and roll. Due to the remotenature of a catheterization treatment, the elongate member manipulator1300 will be located a large distance from the tip of the guide catheter1054. The insert function assumes the guide wire has high axialstiffness relative to frictional forces between the guide wire and theinner wall of the guide catheter 1054 as well as forces due to contactwith tissue. Thus moving the wire a certain distance proximally shouldcorrespond directly to motion distal to the catheter tip. FIG. 120illustrates a control scheme for control of the elongate membermanipulator 1300. The control scheme is a more generalized version ofthe previously described control schemes shown in FIGS. 118A-D. In FIG.120, the elongate member manipulator inserts and rolls a guide wireaccording to commands from a master input device. In the currentlydescribed variation, the master input device is the joystick and controlconsole. The controller translates the desired actions into voltages andcurrents which are applied to the guide wire manipulator motor.

As described in detail in the aforementioned incorporated references,both the sheath catheter assembly 1040 and guide catheter assembly 1050may be mounted on separate carriages that are motor actuated to providea propelling motion in the insert and retract directions of the guidecatheter 1054 and sheath catheter 1044. In one variation, the elongatemember manipulator 1300 is fixably mounted to the same carriage as theguide catheter assembly 1050. By mounting the elongate membermanipulator in this fashion, buckling of the guide wire can be minimizedby locating the elongate member manipulator 1300 as close to theproximal end of the guide catheter 1054 as possible and/or maintaining aconstant gap between the elongate member manipulator 1300 and guidecatheter 1054 proximal end. The constant gap also avoids an inadvertentcollision between the elongate member manipulator 1300 and guidecatheter assembly 1050. FIGS. 121A-B illustrate a block diagram showinga variation where an elongate member manipulator 1300 is coupled to theguide catheter assembly 1050 and the sheath catheter assembly 1040. Thesheath catheter assembly 1040 may be independently actuated in theinsert and retract direction from the guide catheter assembly 1050 andthe elongate member manipulator 1300. The elongate member manipulator1300 and guide catheter assembly may be coupled to the same carriage andthus are inserted or retracted on that carriage simultaneously.

An example of a controls scheme will be described herein for thisconfiguration of a guide wire, guide catheter, and sheath catheter. Aguide wire is a thin flexible elongated rod. In one example, the guidewire is sized at roughly half a millimeter in diameter and about a meterlong used during non-invasive vascular catheterization procedures,generally for medical treatment. It typically has an extremely flexibledistal tip which prevents interaction trauma by deflecting againsttissue rather than scraping or piercing tissue when inserted through apatient's vasculature. One possible mode of operation for use of a guidewire includes positioning the guide wire, holding it in a staticallyfixed position, and then sliding a catheter over the guide wire. Whenthe guide wire is used in conjunction with the robotically steerableguide catheter 1054 and sheath catheter 1044 as in this variation, it isconvenient for the operator to have the guide wire be controllable bythe robotic system to allow for coordinated motion of the elongatemember manipulator 1300 with the guide catheter 1054 and sheath catheter1044. FIG. 122 shows a controller flow diagram for the construction of amovable carriage and a coupled elongate member manipulator as shown inFIG. 121B. The desired action from the master device is coordinated withthe actions of other instrument driver 1016 axes to create a jointcommand for the insert/retract and roll motors. Finally, these commandsare applied to the elongate member manipulator motors with a servocontroller to achieve the desired position.

Because the guide catheter assembly 1050 is coupled to the elongatemember manipulator 1300, as the guide catheter is inserted, the guidewire is inserted an identical distance. In order to maintain a staticposition of the guide wire 1060 while sliding the guide catheter 1054over the guide wire 1060, the guide wire may be retracted an equaldistance using the guide wire manipulator actuation previously describedand shown in FIG. 120. FIG. 121A shows the insert distances traveled as,x_(S), x_(G), and x_(wd). Where:

x_(S) = insert  distance  for  sheath  catheterx_(G) = insert  distance  for  guide  catheterx_(wd) = insert  distance  for  guide  wire

In order for the position of the guide wire 1060 to remain constant suchthat the guide wire 1060 is static, Δx_(wd)=0 and the commanded guidewire position (x_(wp)) can be represented as:

$\begin{matrix}{x_{wp} = {x_{wd} - x_{G}}} & (1)\end{matrix}$

The movement of the sheath catheter is independent of the guide carriageso is not included in this calculation.

In another variation shown in FIG. 121B, the elongate member manipulator1300 and guide catheter assembly 1050 can be mounted to the samecarriage as the sheath catheter assembly 1040. Thus as the sheathcatheter 1044 is inserted, the guide catheter 1054, and guide wire 1060are inserted the same amount. Additionally, if the guide carriage isindependently inserted, the guide catheter 1054 and guide wire 1060 areindependently inserted a separate amount. Thus in order for the positionof the guide wire 1060 to be static, Δx_(wd)=0 and the commanded guidewire position (x_(wp)) can be represented as:

$\begin{matrix}{x_{wp} = {x_{wd} - X_{G} - X_{S}}} & (2)\end{matrix}$

In one variation, the elongate member manipulator may not retract theguide wire behind the distal tip of the guide catheter such that theguide wire will be immediately available for guiding when desired by theoperator. If the guide wire is retracted within the catheter tip, itwill need to recover this distance before being available to thephysician. This requires the actual guide wire insert position, andguide catheter insert position to be known relative to one another andcontrolled precisely. Various sensors have been previously described tomeasure insert of both the guide catheter and the guide wire.

Static friction between the guide wire and the guide catheter can impededistal rotational motion of the guide wire when the proximal end isrolled. Because of the moderate torsional stiffness of guide wires,there can be multiple revolutions of angular difference between thedistal and proximal ends of the wire just due to frictional forces. Oncethe static friction releases, the wire may rotate rapidly until frictionstops the motion again creating an undesirable whipping motion. Onemethod of overcoming the static portion of friction is to dither theguide wire insertion while rolling by using the propelling actuationprovided by the elongate member manipulator to repeatedly insert andretract the guide wire 1060 a small distance. The axial stiffness willtranslate motion through the length of the wire and proximal rotationshould translate more directly to distal rotation. The dithering motioncould be configured to avoid inserting the wire past the point commandedby the operator during the insert dithering.

Manually operated guide wires include an inherent feedback to theoperator as resistance to insert and roll felt by the operator's hands.Thus it could be desirable to provide feedback to the operator duringrobotic control. Feedback could include but not be limited to visual,audible and haptic feedback. Live fluoroscopic images showing thelocation of the guide wire and catheters relative to patient anatomycould be provided on the display as well as a virtual guide wire image.By monitoring the position of the guide wire in relation to the positionof the catheter, i.e. registering the guide wire to the catheter frame,the guide wire position may be displayed. One method of determiningrelative positions would be to display a virtual wire extended beyondthe catheter tip, to scale with the virtual diameters. A numericaldistance could replace or accompany such a display. Also, the virtualwire could be striped or otherwise patterned to indicate movement asdisplayed in FIG. 123. Another method of registration could include theuse of position sensors including but not limited to EM or fiber sensorsas described in detail in the aforementioned incorporated references.

As previously described, insert force can be measured by the elongatemember manipulator. Measured force may be simply displayed for theoperator to see how much force the manipulator is applying to move thewire. Further, if the wire inputs are provided with a haptic device,this force could be conveyed to the operator in a way such as with adirect force resistance in the haptic device or with a vibrationproportional to force. The force may also be used to detect anomalousinsertion conditions in order to avoid or compensate. High insertionforces may cause the wire to buckle between the manipulator andcatheter. When force exceeds a threshold, the insertion should be haltedto avoid buckling or abrading the surfaces of the wire or catheter.Force may also be used to scale motion in an analog manner. For example,slave motion may correspond directly to master commands, so the mastermotion may be de-scaled to result in less slave motion as described indetail in aforementioned incorporated references.

Additionally, any feedback sensors including but not limited toposition, force, and encoders including redundant encoders as well askinematic data for commanded guide wire position can all be continuouslymonitored to detect errors if there is a data mismatch.

The above variations of systems and manipulators may be used with guidewires and/or any other elongate member or instrument.

IX. Instinctive Drive

Referring to FIG. 128A, an overview of an embodiment of a controlssystem flow is depicted. A master computer 2400 running master inputdevice software, visualization software, instrument localizationsoftware, and software to interface with operator control stationbuttons and/or switches is depicted. In one embodiment, the master inputdevice software is a proprietary module packaged with an off-the-shelfmaster input device system, such as the Phantom™ from Sensible DevicesCorporation, which is configured to communicate with the Phantom™hardware at a relatively high frequency as prescribed by themanufacturer. Other suitable master input devices are available fromsuppliers such as Force Dimension of Lausanne, Switzerland. The masterinput device 12 may also have haptics capability to facilitate feedbackto the operator, and the software modules pertinent to suchfunctionality may also be operated on the master computer 2400.Preferred embodiments of haptics feedback to the operator are discussedin further detail below.

The term “localization” is used in the art in reference to systems fordetermining and/or monitoring the position of objects, such as medicalinstruments, in a reference coordinate system. In one embodiment, theinstrument localization software is a proprietary module packaged withan off-the-shelf or custom instrument position tracking system, such asthose available from Ascension Technology Corporation, Biosense Webster,Inc., Endocardial Solutions, Inc., Boston Scientific (EP Technologies),Medtronic, Inc., and others. Such systems may be capable of providingnot only real-time or near real-time positional information, such asX-Y-Z coordinates in a Cartesian coordinate system, but also orientationinformation relative to a given coordinate axis or system. Some of thecommercially-available localization systems use electromagneticrelationships to determine position and/or orientation, while others,such as some of those available from Endocardial Solutions, Inc.—St JudeMedical, utilize potential difference or voltage, as measured between aconductive sensor located on the pertinent instrument and conductiveportions of sets of patches placed against the skin, to determineposition and/or orientation. Referring to FIGS. 128B and 128C, variouslocalization sensing systems may be utilized with the variousembodiments of the robotic catheter system disclosed herein. In otherembodiments not comprising a localization system to determine theposition of various components, kinematic and/or geometric relationshipsbetween various components of the system may be utilized to predict theposition of one component relative to the position of another. Someembodiments may utilize both localization data and kinematic and/orgeometric relationships to determine the positions of variouscomponents.

As shown in FIG. 128B, one preferred localization system comprises anelectromagnetic field transmitter 2406 and an electromagnetic fieldreceiver 2402 positioned within the central lumen of a guide catheter2090 (which may be one or more of the embodiments of the catheterdescribed herein). The transmitter 2406 and receiver 2402 are interfacedwith a computer operating software configured to detect the position ofthe detector relative to the coordinate system of the transmitter 2406in real or near-real time with high degrees of accuracy. Referring toFIG. 128C, a similar embodiment is depicted with a receiver 2404embedded within the guide catheter 2090 construction. Preferred receiverstructures may comprise three or more sets of very small coils spatiallyconfigured to sense orthogonal aspects of magnetic fields emitted by atransmitter. Such coils may be embedded in a custom configuration withinor around the walls of a preferred catheter construct. For example, inone embodiment, two orthogonal coils are embedded within a thinpolymeric layer at two slightly flattened surfaces of a catheter 2090body approximately ninety degrees orthogonal to each other about thelongitudinal axis of the catheter 2090 body, and a third coil isembedded in a slight polymer-encapsulated protrusion from the outside ofthe catheter 2090 body, perpendicular to the other two coils. Due to thevery small size of the pertinent coils, the protrusion of the third coilmay be minimized. Electronic leads for such coils may also be embeddedin the catheter wall, down the length of the catheter body to aposition, preferably adjacent an instrument driver, where they may berouted away from the instrument to a computer running localizationsoftware and interfaced with a pertinent transmitter.

In another similar embodiment (not shown), one or more conductive ringsmay be electronically connected to a potential-difference-basedlocalization/orientation system, along with multiple sets, preferablythree sets, of conductive skin patches, to provide localization and/ororientation data utilizing a system such as those available fromEndocardial Solutions—St. Jude Medical. The one or more conductive ringsmay be integrated into the walls of the instrument at variouslongitudinal locations along the instrument, or set of instruments. Forexample, a guide instrument may have several conductive ringslongitudinally displaced from each other toward the distal end of theguide instrument, while a coaxially-coupled sheath instrument maysimilarly have one or more conductive rings longitudinally displacedfrom each other toward the distal end of the sheath instrument—toprovide precise data regarding the location and/or orientation of thedistal ends of each of such instruments.

Referring back to FIG. 128A, in one embodiment, visualization softwareruns on the master computer 2400 to facilitate real-time driving andnavigation of one or more steerable instruments. In one embodiment,visualization software provides an operator at an operator controlstation, such as that depicted in FIG. 1, with a digitized “dashboard”or “windshield” display to enhance instinctive drivability of thepertinent instrumentation within the pertinent tissue structures.Referring to FIG. 128D, a simple illustration is useful to explain oneembodiment of a preferred relationship between visualization andnavigation with a master input device 12. In the depicted embodiment,two display views 2410, 2412 are shown. One preferably represents aprimary 2410 navigation view, and one may represent a secondary 2412navigation view. To facilitate instinctive operation of the system, itis preferable to have the master input device coordinate system at leastapproximately synchronized with the coordinate system of at least one ofthe two views. Further, it is preferable to provide the operator withone or more secondary views which may be helpful in navigating throughchallenging tissue structure pathways and geometries.

Using the operation of an automobile as an example, if the master inputdevice is a steering wheel and the operator desires to drive a car in aforward direction using one or more views, his first priority is likelyto have a view straight out the windshield, as opposed to a view out theback window, out one of the side windows, or from a car in front of thecar that he is operating. The operator might prefer to have the forwardwindshield view as his primary display view, such that a right turn onthe steering wheel takes him right as he observes his primary display, aleft turn on the steering wheel takes him left, and so forth. If theoperator of the automobile is trying to park the car adjacent anothercar parked directly in front of him, it might be preferable to also havea view from a camera positioned, for example, upon the sidewalk aimedperpendicularly through the space between the two cars (one driven bythe operator and one parked in front of the driven car), so the operatorcan see the gap closing between his car and the car in front of him ashe parks. While the driver might not prefer to have to completelyoperate his vehicle with the sidewalk perpendicular camera view as hissole visualization for navigation purposes, this view is helpful as asecondary view.

Referring still to FIG. 128D, if an operator is attempting to navigate asteerable catheter in order to, for example, contact a particular tissuelocation with the catheter's distal tip, a useful primary navigationview 2410 may comprise a three dimensional digital model of thepertinent tissue structures 2414 through which the operator isnavigating the catheter with the master input device 12, along with arepresentation of the catheter distal tip location 2416 as viewed alongthe longitudinal axis of the catheter near the distal tip. Thisembodiment illustrates a representation of a targeted tissue structurelocation 2418, which may be desired in addition to the tissue digitalmodel 2414 information. A useful secondary view 2412, displayed upon adifferent monitor, in a different window upon the same monitor, orwithin the same user interface window, for example, comprises anorthogonal view depicting the catheter tip representation 2416, and alsoperhaps a catheter body representation 2420, to facilitate theoperator's driving of the catheter tip toward the desired targetedtissue location 2418.

In one embodiment, subsequent to development and display of a digitalmodel of pertinent tissue structures, an operator may select one primaryand at least one secondary view to facilitate navigation of theinstrumentation. By selecting which view is a primary view, the user canautomatically toggle a master input device 12 coordinate system tosynchronize with the selected primary view. In an embodiment with theleftmost depicted view 2410 selected as the primary view, to navigatetoward the targeted tissue site 2418, the operator should manipulate themaster input device 12 forward, to the right, and down. The right viewwill provide valued navigation information, but will not be asinstinctive from a “driving” perspective.

To illustrate: if the operator wishes to insert the catheter tip towardthe targeted tissue site 2418 watching only the rightmost view 2412without the master input device 12 coordinate system synchronized withsuch view, the operator would have to remember that pushing straightahead on the master input device will make the distal tip representation2416 move to the right on the rightmost display 2412. Should theoperator decide to toggle the system to use the rightmost view 2412 asthe primary navigation view, the coordinate system of the master inputdevice 12 is then synchronized with that of the rightmost view 2412,enabling the operator to move the catheter tip 2416 closer to thedesired targeted tissue location 2418 by manipulating the master inputdevice 12 down and to the right.

Instinctive drive techniques have been described in U.S. patentapplication Ser. No. 11/176,598, filed on Jul. 6, 2005, the entiredisclosure of which is expressly incorporated by reference herein forall purposes.

The synchronization of coordinate systems described herein may beconducted using fairly conventional mathematic relationships. Forexample, in one embodiment, the orientation of the distal tip of thecatheter may be measured using a 6-axis position sensor system such asthose available from Ascension Technology Corporation, Biosense Webster,Inc., Endocardial Solutions, Inc., Boston Scientific (EP Technologies),and others. A 3-axis coordinate frame, C, for locating the distal tip ofthe catheter, is constructed from this orientation information. Theorientation information is used to construct the homogeneoustransformation matrix, T_(CO) ^(GO), which transforms a vector in theCatheter coordinate frame “C” to the fixed Global coordinate frame “G”in which the sensor measurements are done (the subscript C₀ andsuperscript G₀ are used to represent the O'th, or initial, step). As aregistration step, the computer graphics view of the catheter is rotateduntil the master input and the computer graphics view of the catheterdistal tip motion are coordinated and aligned with the camera view ofthe graphics scene. The 3-axis coordinate frame transformation matrixT_(Gref) ^(GO) for the camera position of this initial view is stored(subscripts _(Gref) and superscript _(Cref) and for the global andcamera “reference” views). The corresponding catheter “reference view”matrix for the catheter coordinates is obtained as:

T_(Cref)^(CO) = T_(GO)^(CO)T_(Gref)^(GO)T_(Cref)^(Gref) = (T_(CO GO))⁻¹T_(Gref)^(GO)T_(Ci)^(Gi)

Also note that the catheter's coordinate frame is fixed in the globalreference frame G, thus the transformation matrix between the globalframe and the catheter frame is the same in all views, i.e., T_(CO)^(GO)=T_(Cref) ^(Gref)=T_(Ci) ^(Gi) for any arbitrary view i. Thecoordination between primary view and master input device coordinatesystems is achieved by transforming the master input as follows: Givenany arbitrary computer graphics view of the representation, e.g. thei'th view, the 3-axis coordinate frame transformation matrix T_(Ci)^(GO) of the camera view of the computer graphics scene is obtained fromthe computer graphics software. The corresponding cathetertransformation matrix is computed in a similar manner as above:

T_(Ci)^(CO) = T_(GO)^(CO)T_(Gi)^(GO)T_(Ci)^(Gi) = (T_(Co)^(GO))⁻¹T_(Gi)^(GO)T_(Ci)^(Gi)

The transformation that needs to be applied to the master input whichachieves the view coordination is the one that transforms from thereference view that was registered above, to the current ith view, i.e.,T_(Cref) ^(Ci). Using the previously computed quantities above, thistransform is computed as:

T_(Cref)^(Ci) = T_(CO)^(Ci)T_(Cref)^(CO)

The master input is transformed into the commanded catheter input byapplication of the transformation T_(Cref) ^(Ci). Given a command input

$r_{master} = \begin{bmatrix}x_{master} \\y_{master} \\z_{master}\end{bmatrix}$

one may calculate:

$r_{catheter} = {\begin{bmatrix}x_{catheter} \\y_{catheter} \\z_{catheter}\end{bmatrix} = {T_{Cref}^{Ci}\begin{bmatrix}x_{master} \\y_{master} \\z_{master}\end{bmatrix}}}$

Under such relationships, coordinate systems of the primary view andmaster input device may be aligned for instinctive operation.

In one or more of the embodiments, the user interface of the roboticsystem may be configured to allow a user to register (or align) a realimage of a catheter (e.g., a fluoroscopic image) with an image of acomputer model of the catheter. This results in the real image catheterbeing in a same orientation as that of the model image, thereby allowinga user to instinctively drive the catheter (e.g., so that a command tomove the catheter model to the right will result in the catheter movingto the right in the reference frame of the real image). The model imagemay be generated using different techniques in different embodiments. Insome embodiments, the model image may be generated by a processor usingkinematic information (e.g., stress, strain, curvature, amounts oftensions in respective pull wires inside the catheter, etc.) regardingthe catheter. In other embodiments, the model image may be generatedusing a light signal transmitted through a fiber optic that extendsalong a length of the catheter. Techniques for determining a geometricconfiguration of an elongated member using light transmitted through afiber optic have been describe in U.S. patent application Ser. No.11/690,116, filed on Mar. 22, 2007, now abandoned, the entire disclosureof which is expressly incorporated by reference herein. In furtherembodiments, the model image of the catheter may be generated (e.g., bya processor) based at least in part on localization data obtained fromelectromagnetic sensors. Electromagnetic sensors for obtaininglocalization data for a medical device are well known in the art, andtherefore, will not be described in detail herein.

The act of registration (or alignment) between a real image of thedevice and a model image may be carried out in different manners indifferent embodiments. For example, in some embodiments, an alignmentprocess may be performed, wherein the user adjusts one or a few inputsto line up a graphic on screen with a fluoro image of the actualcatheter. In one such embodiment, the user can adjust one slider on atouchscreen (or a control at a station) to rotate a virtualrepresentation of the catheter within the plane of the fluoro image toalign its heading direction at a prescribed location (e.g., location ofa control ring in the leader) to that of the real catheter in the fluoroimage, and a second slider (or a second control at the station) torotate the virtual catheter in or out of plane to align its tilt angleto that of the real catheter. In order to align the roll angle, the usermay put a slight bend on the catheter (e.g., so that a length of thecatheter may appear as a straight line when looking from a proximal ordistal end) and rotate it until the bend is aligned with a bend of anactual catheter. For example, the virtual representation of the catheter(in a bent configuration) may be moved using a control (e.g., slider ina touch screen) to align its roll with a roll of the actual catheterthat also has a bent configuration. In further embodiments, instead ofrotating the catheter, in order to avoid unnecessary catheter movementsinside the body, the user may rotate the fluoro C-arm until the catheterbend is in the imaging plane, pointing either to the left or right inthat plane. Variations on this process include using other userinterfaces or input devices, such as using the trackball on the pendantinstead of touchscreen sliders to align the heading and/or tilt anglesof the catheter. In further embodiments, the alignment process describedabove may not be needed. For example, in some cases, if localizationinformation for the catheter is available, then the alignment processmay not be performed (unless the localization is imperfect and needs tobe adjusted).

Referring back to embodiment of FIG. 128A, the master computer 2400 alsocomprises software and hardware interfaces to operator control stationbuttons, switches, and other input devices which may be utilized, forexample, to “freeze” the system by functionally disengaging the masterinput device as a controls input, or provide toggling between variousscaling ratios desired by the operator for manipulated inputs at themaster input device 12. The master computer 2400 has two separatefunctional connections with the control and instrument driver computer2422: one 2426 for passing controls and visualization related commands,such as desired XYZ (in the catheter coordinate system) commands, andone 2428 for passing safety signal commands. Similarly, the control andinstrument driver computer 2422 has two separate functional connectionswith the instrument and instrument driver hardware 2424: one 2430 forpassing control and visualization related commands such asrequired-torque-related voltages to the amplifiers to drive the motorsand encoders, and one 2432 for passing safety signal commands.

In some cases, during use of the robotic system, it may or may not bepossible to place the catheter at a desired position, depending on howthe catheter is driven. This may be illustrated in the example shown inFIGS. 128E and 128F. The catheter tip is shown in a same Cartesianposition relative to a reference frame (which may be a distal tip of thesheath, or any location along a length of the catheter or the sheath) inboth FIGS. 128E and 128F, while in very different joint configurations.If the catheter were in the configuration shown in FIG. 128E, and theuser wants to reach a position incrementally to the left of the cathetertip, but the catheter is already at its maximum articulation, then thedesired position of the catheter tip could not be achieved byincrementally moving the tip of the catheter to the left. However,because the desired position is still in the overall workspace, it couldbe achieved by decreasing the articulation of the catheter, and theinsertion, in order to achieve the configuration shown in FIG. 128F. Inone approach, an extra constraint is added, such as by keeping aconstant catheter insertion. In this approach, the user is hapticallyconstrained to the surface of a “dome”, as shown in FIG. 128G, and mayorient the catheter but not insert or deinsert it. In thisimplementation, a proxy position is computed using the hapticimplicit-surface (e.g., a cardiod-shaped implicit surface intersectedwith a plane) proxy algorithm, and a force is returned based on a vectorbetween the device position and the proxy position regardless of whetherthe device position is inside or outside of the implicit surface. Insome embodiments, an artificial limit (e.g., a prescribed velocitylimit) for the commanded catheter's articulation motion may be providedto prevent the catheter from moving faster than the robot cancommand/control it. The difference in position between the proxy and thecatheter may then be use to provide force feedback that the user istrying to move the catheter too quickly.

In some embodiments, a two-handed driving technique may be provided, inwhich the user may insert or deinsert the catheter using a first control(e.g., a pendant button), and orient (e.g., steer) it using a secondcontrol (e.g., IMC). The two controls may be configured to allow theuser to operate them simultaneously, or one after the other. In oneimplementation, the user interface is configured to allow the user tocontrol both the pendant-based insertion and the IMC-based orientationsimultaneously. In another embodiment, two functional modes for IMCdriving may be provided. In one mode, the user orients the catheter aspreviously described. In the other mode, the user may insert or deinsertthe catheter by pushing against the haptic constraint(s). In some cases,the IMC is haptically constrained to a line when in this operation modebecause the user may “slip” along the convex top of the dome when tryingto push inward to de-insert the catheter.

In other embodiments, a haptic “divot” may be placed in the workspacewhen de-inserting. Various techniques may be used to allow switchingbetween the different modes. For example, in some embodiments, whenclutching the IMC, the user may start out in the orientation mode, butwhen the force applied against the workspace exceeds a certainthreshold, the user may be switched into the insert-deinsert mode. Inother embodiments, the mode may be controlled by a secondary IMC buttonor a foot pedal or a pendant button.

In some embodiments, as the user is driving the catheter using therobotic system, the user interface displays an image of the catheter(which may be a real image, or a computer generated model), and thehaptic dome of FIG. 27 that follows the distal end of the catheter. Thedome represents a constraint for the distal end of the catheter so thatat least a part (e.g., the distal tip) of the distal end of the catheteris required to be on an outline of the dome regardless of how thecatheter is driven. For example, in one implementation, the userinterface provides a first control for allowing the user to advance orretract the catheter, and a second control for allowing the user tosteer the catheter. In such cases, if the user attempts to advance orretract the catheter, the tip of the catheter will be constrained tofollow the outline of the dome. As a result, the tip of the catheter may“slide” along the outline of the dome in response to the command toadvance or retract the catheter. Similarly, if the user attempts tosteer the tip of the catheter, the tip of the catheter will also beconstrained to follow the outline of the dome, thereby causing the tipof the catheter to “slide” along the outline of the dome in response tothe command to steer the catheter. In some embodiments, advancement orretraction of the catheter will change the size of the doom as it isdisplayed in the screen, while a steering of the catheter will notchange the size of the doom. In some embodiments, the dome may have acardiod shape. In other embodiments, the dome may have other shapes. Insome cases, the system is configured to also provide force feedback atthe user interface for the user based on the haptic dome. For example,if the processor determines that a command for positioning (advancement,retraction, and/or steering) of the catheter may result in the distaltip of the catheter being away from the outline of the dome, then theuser interface will provide a force feedback to indicate to the userthat the tip of the catheter is being “pulled” or “compressed” by theoutline of the dome. If the user “feels” a restraining force from theuser interface as he/she is commanding the catheter to move, the imageof the haptic dome will allow the user to see why that may be the case.

In some of the embodiments described herein, the system may also providespeed control for positioning the catheter so that the tip of thecatheter cannot be positioned (e.g., advanced, retracted, and/orsteered) too fast. In one implementation, a speed limit may be enteredinto the system. In such cases, if the user attempts to position thecatheter in a way that exceeds the speed limit, the processor maycontrol the positioning of the catheter so that it stays below the speedlimit, and may cause the user interface to provide a tactile feedbackindicating that the speed of the catheter is being controlled.

In some embodiments, the dome reflects the kinematic articulationworkspace of the elongate member. The dome is not limited to anyparticular shape, and may have a cardioid shape, a spherical shape, acone shape, or any of other shapes. In some embodiments, the dome shapemay be user defined. In other embodiments, the dome shape may bedetermined by the processor. In one implementation, in order tocalculate the shape of the dome, the software starts with a cardioidshape (or another arbitrary shape), then searches around that surfacefor the true limits of the reach by the elongate member.

X. Sterile Adaptor

As described in detail in application Ser. No. 12/614,349 issued as U.S.Pat. No. 8,720,448 on May 13, 2014, previously incorporated byreference, during surgical robotic procedures, common practice is toplace a sterile drape over a robotic assembly such as the previouslydescribed instrument driver, then attach sterilized tools onto therobotic assembly over the drape. In this way, the robotic side of thedrape is in a non-sterile environment while the surgical side is in asterile environment. It is often desirable to remove a tool and replaceit with an alternative tool which serves an alternative function, thenexchange the tools again such that the original tool is replaced.However, once a tool is initially engaged onto the non-sterile robot, itbreaks the sterile field making the tool non-sterile, preventing a userfrom re-installing it without re-sterilizing it. Thus in practice, auser must either sterilize a tool before re-installing it or must treatthe tool as a disposable without the capability of re-installation.Re-sterilization is an impractical solution during a procedure and whilea disposable tool can be sterilized and used on a later date, it couldbe costly to continue using new tools during the procedure.Additionally, liquids such as blood or saline are often spilled onto thedrape during tool exchange. While tools are removed from anatomy, theyare often contaminated with blood that spills specifically in the areawhere the tool is coupled to the robotic assembly. It is preferable thatliquids do not leak into the robotic assembly which may cause a loss offunctionality in the electro-mechanical assemblies within the robot.Thus an interface apparatus that prevents fluid ingress whiletransferring drive motion across a sterile barrier without breaking thesterile barrier may be desirable.

One variation of a drive interface apparatus is illustrated withreference to FIGS. 129a-129c . FIG. 129a illustrates a version of thepreviously described instrument driver 16 which includes a sheath outputplate 3006 and guide output plate 3008. A sheath splayer 3003 and aguide splayer 3005 are each mounted indirectly to the sheath outputplate 3006 and guide output plate 3008 respectively. It should be notedthat the sheath and guide mounting plates along with the sheath andguide splayers are substantially similar in construction andfunctionality. By way of example, the sheath splayer and sheath outputplate will be later described with the understanding that the sameconstruction and functionality can apply to the guide splayer and guideoutput plate.

FIG. 129b shows a zoomed in view of a front portion of the instrumentdriver 16 better illustrating the sheath splayer 3003, a drive interfaceapparatus 3004, a drape assembly 1900, and the sheath output plate 3006.FIG. 129c illustrates an exploded view of the assembly of FIG. 129b .The sheath splayer 3003 is removably coupled to the interface apparatus3004 which in turn is removably coupled to the sheath output plate 3006.The drape assembly 1900 is compressed between the drive interfaceapparatus 3004 and the sheath output plate 3006. For clarity, onlyportions of the drape assembly 1900 are shown. The full drape assembly1900 will be described in detail later

FIGS. 130a and 130b illustrate a top and bottom view respectively of avariation of the sheath output plate 3006. FIG. 130c illustrates abottom exploded view of the sheath output plate 3006 which includes abase plate 3010, sliding latches 3012, four sliding springs 3014, andtwo retaining plates 3016. FIGS. 131a-b illustrates a top and bottomperspective view of the base plate 3010 which includes drive interfacealignment holes 3026, contact pin holes 3028, cutouts 3018, latch walls3020, and latch pins 3022. The sliding latches 3012 can fit into thecutout 3018 in the bottom of the base plate 3010 with the two slidingsprings 3014 each compressed between a ridge of the sliding latch 3012and the latch wall 3020 in the cutout 3018. The retaining plates 3016can be fixed to the base plate 3010 with screws (not shown in thefigures) holding the sliding latches 3012 and sliding springs 3014 inplace. By way of example, the base plate 3010 can be made of 6061-T6aluminum, the latches can be made of 316 stainless steel, and theretaining plates 3016 can be made of high hardness stainless steel.

FIG. 131c illustrates a variation of the guide output plate 3008 whichcan utilize an alternatively shaped guide output base plate 3024configured to provide a mount for a clamp holding the handle of aworking catheter. The main body 3025 of the guide output plate 3008 canremain substantially identical to that of the sheath output plate 3006.Thus the same type of spring loaded sliding latch mechanisms describedfor the sheath output plate 3006 can be used for the guide output plate3008. For both the guide and sheath output plates 3008,3006 the slidinglatches can be used to attach and detach the drive interface apparatus3004 as will be described in detail later.

FIG. 132a-132b illustrate top and bottom perspective views of the driveinterface apparatus 3004 while FIG. 132c illustrates an exploded view.The drive interface apparatus 3004 can include a drive interface base3030, drive interface pulley shafts 3048, drive interface shaft pins3050, conductive spring loaded EEPROM pins 3052, and a splash deflector3054.

FIG. 133a-133b illustrates top and bottom perspective views of the driveinterface base 3030 which includes top static latches 3032, bottomstatic latches 3034, pulley holes 3036, pin holes 3038, splayer holes3040, and output plate alignment pins 3042. The top and bottom staticlatches 3032, 3034 can be non-adjustable, non-movable protrusions whichas will be described in detail later could be used to lock the splayer3002 to the drive interface apparatus 3004 and the drive interfaceapparatus 3004 to either the sheath or guide output plates 3006,3008.The splayer holes 3040 and output plate alignment pins 3042 can be usedto help with installation of the drive interface apparatus 3004 and thesheath splayer 3003.

FIGS. 134a-134b illustrate top and bottom views of the drive interfacebase 3030 with the drive interface pulley shafts 3048 and EEPROM pins3052 installed into the pulley holes 3036 and pin holes 3038respectively. The bottom portions of drive interface pulley shafts 3038and EEPROM pins 3052 protrude through the drive interface base 3030while resting within the drive interface base 3030. Referring back toFIGS. 4132a and 132c , the splash deflector 3044 which is illustratedwith cutouts that provide clearance for the top static latches 3032,drive interface pulley shafts 3048, and EEPROM pins 3052 can beinstalled onto the drive interface base 3030. The splash deflector 3044not only provides for exclusion of debris and liquids but it alsoconstrains the drive interface pulley shafts 3048 from movement in thevertical and horizontal plane while allowing free rotational movementabout their respective axes.

FIG. 135a-135c illustrates perspective and zoomed in views of the drapeassembly 1900. Among other components that operate with a guide wiremanipulator which will be described later, the drape assembly includes adrape body 1901, a sheath foam pad 1902, a guide foam pad 1904,protective tabs 1906, and an alignment aid 1908. The sheath foam pad1902 is similar in construction to the guide foam pad 1904, eachprovided with cutouts to mate with guide or sheath output plates 3008,3006 as well as the drive interface apparatus 3004. The sheath and guidefoam pads 1902, 1904 can be constructed from any number of compressiblematerials including but not limited to polyurethane foam while theprotective tabs and alignment aid can be made of High-densitypolyethylene (HDPE). The drape body 1901 can be constructed of any typeof sheer plastic including but not limited to polyethelene.

FIGS. 136a-b illustrate different types of splayers that may be used inconjunction with the previously described drive interface apparatus.FIG. 136a illustrates a perspective view of a variation of the sheathsplayer 3003 while FIG. 136b illustrates a perspective view of avariation of the guide splayer 3005. The sheath splayer 3003 includes asplayer body 3002, a sheath active valve assembly 3080, a sheathanti-buckling interface 3074, and a sheath catheter 3000. The guidesplayer 3005 includes a splayer body 3002, a guide flush assembly 3082,a guide anti-buckling interface 3076, and a guide catheter 3001.

Referring to FIG. 136c the sheath splayer 3003 is shown with a sheathcover 3062 exploded from the remaining components of the sheath splayerto illustrate how the sheath active valve 3080, sheath catheter 3000 andsheath anti-buckling interface 3074 are integrated with the splayer body3002. The sheath splayer 3003 has a substantially identical splayer body3002 to the guide splayer 3005 so integration of the guide flushassembly 3082, the guide anti-buckling interface 3076, and the guidecatheter 3001 is similar.

Referring to FIG. 137a-c , the splayer body 3002 will be described inmore detail. FIG. 137a illustrates a top perspective view, FIG. 137billustrates a bottom perspective view, and FIG. 137c illustrates anexploded view. The splayer body 3002 can include a splayer base 3060, asplayer cover 3062, splayer pulley assemblies 3064, a splayer ID chip3066, an ID chip cover 3070, a splayer presence magnet 3072, and splayerbody screws 1073.

The splayer cover 3062 shown in FIG. 138 can include a pair of splayerlatches 3084 coupled to pair of urethane based compliant members 3086allowing the latches to be repositioned with applied manual forces.Perspective and exploded views of the splayer pulley assembly 3064 areillustrated in FIGS. 138a-138b respectively. The pulley assembly 3064includes a pulley 3102, a set of outer races 3104, a set of ball cages3110, a set of ball bearings 3108, and a set of retainer clips 3106. Thepulley 3102 can be constructed of plastic and provided with an internalspline 3112 profile and with a feature 3114 for coupling with a pullwire crimp ball located at the end of a catheter pull wire or controlwire (well known in the art and described in detail in applicationspreviously incorporated by reference). The retainer clips 3106 fit ontothe pulley 3102 to hold the crimp balls (not shown) and bearings 3108 inplace. The inner races of the ball bearings are integrated into thepulley in order to achieve a low profile package and minimize assemblyprocesses. The pull wire (not shown) is wound around the pulley 3102 andis run down the length of a catheter shaft as previously described. Thesplayer ID chip 3066 includes a pair of pogo pins 3068. The magnet canbe constructed of various materials including but not limited to asingle neodymium magnet. The splayer base 3060 illustrated in FIGS.139a-b can be configured with pulley pockets 3092, an ID chip pocket3094, a magnet pocket 3096, cover mounting holes 3090, and latch holes3091. The bottom of the splayer base 3060 can also include splayeralignment pins 3088.

FIGS. 140a-b illustrate the splayer base 3060 with the splayer pulleyassemblies 3064, splayer ID chip 3066, and splayer presence magnet 3072installed. The splayer pulley assemblies 3064 rest within the pulleypockets 3092 in a manner that allows the each pulley 3102 to rotateabout its own axis within the ball bearing 3108. The splayer presencemagnet 3072 rests in the magnet pocket 3096. The ID chip pocket 3094 issized to recess the ID chip 3094 allowing for a low overall splayerprofile. The ID chip cover 3070 is installed over the splayer ID chip3066, protecting the ID chip while allowing the pogo pins 3068 toprotrude through. To hold the pulley assemblies 3064 in place, thesplayer cover 3062 is mounted to the splayer base 3060 with the splayerbody screws 3073 which fit through the cover mounting holes 3090. Thesplayer latches 3084 fit through the latch holes 3091, protruding out ofthe bottom of the splayer base 3060. While four pulley assemblies 3064are illustrated, alternative variations can include any number of pulleyassemblies 3064 leaving any number of pulley pockets 3092 empty. The IDchip 3094 is used to transfer device information to the instrumentdriver (not shown) while the presence magnet 3072 detects when thesplayer 3003 is installed on the instrument driver.

Referring to FIGS. 141a one method of installation of the drape assembly1900 onto the instrument driver 16 is shown. As shown in FIG. 141b thedrape assembly 1900 is placed on top of the instrument driver 16aligning the sheath foam pad 1902 and to the sheath output plate 3006 sothat the holes in the foam pad 1902 line up with the holes in the outputplate 3006. The same method can be performed for the guide foam pad 1904and the guide output plate 3008.

A first and second drive interface apparatus can now be installed overthe drape assembly 1900 onto the sheath output plate 3006 and guideoutput plate 3008. The following will illustrate a method ofinstallation for the sheath output plate 3006 but it should beunderstood that substantially identical methods may be implemented forthe guide output plate 3008. FIGS. 142 a and 142 b illustrate the driveinterface apparatus 3004 uninstalled and installed respectively onto theinstrument driver 16 with the drape assembly 1900 installed onto thesheath output plate 3006. FIGS. 143a-143c illustrate top and bottomviews of only the sterile face apparatus 3004 uninstalled on the sheathoutput plate 3006 and drape assembly 1900. The drive interface apparatus3004 can be installed over the sheath foam pad 1902 inserting the driveinterface pulley shafts 3048 through the holes in the sterile drape foampad 1902 and output plate 3006 as shown in FIG. 143. The foam pad 1902is compressed between the drive interface apparatus and the outputplates 3004, 3006 creating a seal preventing liquid ingress. The driveinterface pulley shafts 3048 couple to the sleeve receptacles 56 b byengaging the drive interface shaft pins 3050 into notches in the sleevereceptacles 56 b as shown in FIGS. 144a-d . To aid in alignment of thedrive interface apparatus 3004 with the sheath output plate 3006, theoutput plate alignment pins 3042 fit into the drive interface alignmentholes 3026. As the drive interface apparatus 3004 is pressed down ontothe output plate 3006, the ramped bottom static latches 3034 on thedrive interface base 3030 force the spring loaded sliding latches 3012apart allowing the bottom static latches to insert into the latch holes3011. The sliding springs 3014 force the sliding latches apart lockingthe bottom static latches 3034 to the output plate 3006. The slidingsprings 3014 are sized to compress easily enough to allow a one handedpress installation of the drive interface apparatus 3004 while beingstrong enough to expand locking the static latches in place. Toun-install the drive interface apparatus 3004 from the output plate3006, the sliding latches 3012 on the output plate 3006 can be pressedtowards the center of the output plate 3006, releasing the bottom staticlatches 3034 from the output plate 3006.

Once the drive interface apparatus is installed as described above, theguide or sheath splayer 3005, 3003 can be installed and easilyuninstalled onto the drive interface apparatus 3004 without breaking thesterile barrier created by the sterile drape assembly 1900. Referring toFIG. 145a-b , one method of installation of the sheath splayer 3003 tothe drive interface apparatus 3004 is shown. For clarity, the instrumentdriver and drape assembly are not shown. The sheath splayer 3003 can beinstalled to the drive interface apparatus 3004 coupling the splayerpulleys 3102 to the drive interface shafts 3048. The splayer pulleys3102 are free to rotate within the splayer 3003 before installation ontothe drive interface apparatus 3004. Once engaged with the driveinterface pulley shafts 3048, the splayer pulley assemblies 3064 lockonto the drive interface pulley shafts 3048. The splayer pulleys 3102are configured in a similar manner as VHS type with internal splines3112 that are shaped to ensure consistent self alignment of the pulley3102 to the interface pulley shaft 3048 and to aid in minimizinginsertion and removal force of the splayer 3003 from the drive interfaceapparatus 3004 as shown in FIGS. 146a-b which illustrates top views ofthe splayer pulleys 3102 and the interface pulley shafts 3048. Forfurther illustration, FIGS. 147a-b provide various perspective views ofa single splayer pulley 3102 and interface pulley shaft 3048.

To aide in alignment of the sheath splayer to the drive interfaceapparatus, the splayer alignment pins 3088 on the bottom of the splayer3003 can mate with the splayer holes 3040 on the drive interfaceapparatus 3004. To lock the splayer 3003 to drive interface apparatus3004 force applied to the top of the splayer 3003 will force the splayerlatches 3084 to displace until they lock with the top static latches3032 on the drive interface apparatus. The spring force of the compliantmembers 3086 in the splayer cover 3062 force the splayer latches 3084 toreturn to their nominal positions locking the splayer latches 3084 tothe top static latches 3032. In order to remove the splayer 3003 fromthe system, the splayer latches 3084 are compressed by squeezing eitherside of the splayer cover 3062, re-positioning the compliant members3086 and releasing the splayer latches 3084 from the drive interface topstatic latches 3032.

Referring to FIGS. 148a-148b , the transfer of motion from theinstrument driver 16 to the sheath splayer 3003 actuating bending of thesheath catheter 3000 will be shown. FIG. 148a-b illustrates a top andbottom view respectively of the instrument driver 16 with its coverremoved. As previously described, various articulation mechanics 3029including motors, pulleys belts and gears can drive the motorizedrotation of sleeve receptacles 56 b which couple to the drive interfacepulley shafts 3048. As was illustrated in FIGS. 144a-16d , the driveinterface pulleys shafts 3038 can each be provided with drive interfaceshaft pins 3040 that allow the shafts 3038 to be coupled to the sleevereceptacles 56 b. In turn the splayer pulley assemblies 3064 couple tothe drive interface pulley shafts 3038. Thus motorized rotation of thesleeve receptacles ultimately actuates rotation of the splayer pulleyassemblies. As previously described, pull wires that run the length ofthe catheter are controlled by the rotation of the splayer pulleyassemblies 3064 to actuate bending at the distal tips of the catheter.

FIGS. 148a-148b also illustrate the EEPROM pins 3052 of the driveinterface apparatus 3004 which can pass through holes 3028 in the outputplate 3006 in order to couple to a circuit mounted (not shown) beneaththe output plate 3006. Once the splayer 3003 is installed, the pogo pins3068 on the splayer ID chip 3066 make contact with the conductivecontacts 3052 shown allowing the ID chip 3066 to connect to the circuitand transmit catheter parameter data to the robotic system. Also asplayer presence magnet 3072 shown in FIG. 9c is included on the splayer3003 that is detected by a switch (not shown) on the instrument driver16. The presence magnet 3072 can be sized appropriately for detection bya switch mounted within the instrument driver 16 through the driveinterface apparatus 3004.

Referring back to FIGS. 135a-135c , the drape can be provided withprotective tabs to prevent accidental removal of the drive interfaceapparatus during the removal of the splayer. As shown in FIG. 135b-135c, protective tabs 1906 can be provided on the drape body 1901 to coverthe sliding latches 3012 on the output plate 3006 preventing the userfrom accidentally compressing the sliding latches 3006 during aprocedure when the intention is to release the splayer latches 3084. Thedrape assembly 1900 also includes an alignment aid 1908 that may be usedto aid in positioning of the instrument driver 16 to a patient entrysite. When the instrument driver 16 is positioned near the patient, thealignment aid 1908 can be positioned such that its distal tip makescontact with the patient skin setting the distance between theinstrument driver nose and the patient. The alignment aid 1908 can beconfigured such that its overall length is longer than the length of ananti-buckling mechanism (previously described) in its fully compressedstate. Thus the distance between the instrument driver and patient willbe sufficient to allow for installation of the anti-buckling devicewithout causing undesired force of the anti-buckling device on thepatient tissue. The alignment aid may also include an alignment linewhich coincides with the centerline of the instrument driver 16. Thealignment line can be used as a visual aid in alignment of theinstrument driver to an introducer or guide wire inserted in a patientvessel. Since the introducer or guide wire will tend to naturally alignwith the vessel, alignment of the instrument driver to the introducer orguide wire will help with better alignment with the patient vessel. Theposition of the instrument driver 16 can be saved in the system memoryand the alignment aid can be removed from the drape for the remainder ofthe surgical procedure.

Each of the individual variations described and illustrated herein hasdiscrete components and features which may be readily separated from orcombined with the features of any of the other variations. Modificationsmay be made to adapt a particular situation, material, composition ofmatter, process, process act(s) or step(s) to the objective(s), spiritor scope of the present application. Also, any of the features describedherein with reference to a robotic system is not limited to beingimplemented in a robotic system, and may be implemented in anynon-robotic system, such as a device operated manually.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents. Furthermore, where a range of values is provided, everyintervening value between the upper and lower limit of that range andany other stated or intervening value in that stated range isencompassed. Also, any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that described herein (in which case what is present herein shallprevail). The referenced items are provided solely for their disclosureprior to the filing date of the present application. Nothing herein isto be construed as an admission that any claimed invention is notentitled to antedate such material by virtue of prior invention.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art in the field ofthis application.

Although particular embodiments have been shown and described, it willbe understood that they are not intended to limit the claimedinventions, and it will be obvious to those skilled in the art havingthe benefit of this disclosure that various changes and modificationsmay be made. The specification and drawings are, accordingly, to beregarded in an illustrative rather than restrictive sense. The claimedinventions are intended to cover alternatives, modifications, andequivalents.

1.-20. (canceled)
 21. A robotic method, comprising: positioning aflexible elongated member that has a preformed configuration, wherein atleast a part of the flexible elongated member has a first memberdisposed around it, and wherein the first member includes a first wirefor bending the first member or for maintaining the first member in abent configuration; releasing at least some tension in the first wire torelax the first member; and advancing the first member distally relativeto the flexible elongated member while the first member is in a relaxedconfiguration.
 22. The method of claim 21, wherein the act ofpositioning the flexible elongated member comprises advancing theflexible elongated member.
 23. The method of claim 21, wherein the actof positioning the flexible elongated member comprises using a drivemechanism.
 24. The method of claim 21, further comprising re-tensioningthe first wire to stiffen the first member.
 25. The method of claim 24,further comprising repeating the acts of releasing at least some tensionand advancing the first member.
 26. The method of claim 21, wherein atleast a part of the first member has a second member disposed around it,and wherein the second member includes a second wire for bending thesecond member or for maintaining the second member in a bentconfiguration, the method further comprising: releasing at least sometension in the second wire to relax the second member; and advancing thesecond member distally relative to the flexible elongated member whilethe second member is in a relaxed configuration.
 27. The method of claim26, wherein the acts of advancing the first member and the second memberare performed simultaneously so that both the first member and thesecond member are advanced together.
 28. The method of claim 26, whereinthe first member is advanced before the second member.
 29. The method ofclaim 26, further comprising: re-tensioning the first wire to stiffenthe first member; and re-tensioning the second wire to stiffen thesecond member.
 30. The method of claim 21, wherein the first member isadvanced until a distal end of the first member has passed through anopening in a body.
 31. The method of claim 21, wherein the first wire iscoupled to a drivable instrument, and wherein the at least some tensionin the first wire is released by the drivable instrument in response toa control signal received from a processor.
 32. The method of claim 21,wherein the first member is coupled to a drivable instrument, andwherein the first member is advanced by the drivable instrument inresponse to a control signal received from a processor.
 33. A roboticmethod, comprising: inserting a first elongate member and a secondelongate member into a body, wherein the second elongate member isslidably disposed around at least a portion of the first elongatemember; applying tension to one or more steering wires in the firstelongate member to bend a distal portion of the first elongate member;maintaining the applied tension so that the bent distal portion of thefirst elongate member stays stiffened; and advancing the second elongatemember distally relative to the first elongate member while using thestiffened distal portion of the first elongate member as a first guideto direct the second elongate member.
 34. The method of claim 33,further comprising releasing at least some tension in one or moresteering wires in the second elongate member to un-stiffen the secondelongate member before the act of advancing.
 35. The method of claim 33,after the act of advancing, further comprising: releasing at least sometension in the one or more steering wires in the first elongate memberto un-stiffen the first elongate member; applying tension to one or moresteering wires in the second elongate member to bend a distal portion ofthe second elongate member; maintaining the applied tension in the oneor more steering wires in the second elongate member so that the bentdistal portion of the second elongate member stays stiffened; andadvancing the first elongate member distally relative to the secondelongate member while using the stiffened distal portion of the secondelongate member as a second guide to direct the first elongate member36. The method of claim 33, further comprising adjusting the appliedtension.
 37. The method of claim 36, wherein the applied tension isadjusted automatically.
 38. The method of claim 36, wherein the tensionis adjusted to maintain the distal portion of the first elongate memberin a desired bent configuration.
 39. The method of claim 33, wherein thefirst elongate member comprises a catheter, and the second elongatemember comprises a sheath.
 40. The method of claim 33, wherein thesecond elongate member does not include any steering wire.